Regulatory Affairs Analyst Jobs in Maryland
Regulatory affairs analyst jobs in Maryland are concentrated in the Baltimore metro, Rockville, and Silver Spring, where the state's dense cluster of pharmaceutical, biotech, and federal-contractor employers generates steady demand at every experience level. Employers with lasting hiring footprints here include the FDA, Emergent BioSolutions, and Lonza, drawing analysts who specialize in drug regulatory submissions, medical device compliance, and federal agency interactions. The most in-demand subspecialties are pharmaceutical submissions, 510(k) and PMA pathways, and environmental and chemical regulatory compliance tied to Maryland's federal agency presence. See the openings below and apply to the ones that match your experience.
Find JobsOverview
Open roles16
Top employerPrecigen
Top cityBaltimore, MD
Cities hiring9
Work type75% Remote
Top industryHuman Resources
Showing 5 of 16+ Regulatory Affairs Analyst jobs
Manager Regulatory Affairs
We won't show you this job again
Added 1d ago
The Emmes Company, LLC
Manager Regulatory Affairs
Rockville, Maryland
Added 1d ago
Global Regulatory Affairs Director
We won't show you this job again
Added 1d ago
AstraZeneca
Global Regulatory Affairs Director
Gaithersburg, Maryland
Added 1d ago
Regulatory Affairs Support Subject Matter Expert
We won't show you this job again
Added 3d ago
Bering-Alaka`ina Holdings, LLC
Regulatory Affairs Support Subject Matter Expert
Frederick, Maryland
Added 3d ago
Regulatory Affairs Support Specialist
We won't show you this job again
Added 3d ago
Bering-Alaka`ina Holdings, LLC
Regulatory Affairs Support Specialist
Frederick, Maryland
Added 3d ago
Sr Director, Regulatory Affairs CMC *PC 1626
We won't show you this job again
Added 3d ago
Miltenyi Biotec
Sr Director, Regulatory Affairs CMC *PC 1626
Baltimore, Maryland
Added 3d ago
Added 1d ago
Manager Regulatory Affairs
The Emmes Company, LLC·Rockville, Maryland
Job functions:
Remote (US)
Bachelor's degree
201-500 employees
Job Description
Overview:
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Manager, Regulatory Affairs is a regulatory strategy leader who advises both internal teams and external clients, bringing deep regulatory expertise to navigate complex development pathways and facilitate productive dialogue with FDA. This role combines strategic advisory skill with people leadership, managing and developing a small team of Regulatory Affairs professionals while remaining hands-on with the technical and operational work that underpins sound regulatory strategy.
The Manager acts as a trusted partner in client-facing conversations, bringing the regulatory depth and confidence needed to speak knowledgeably on US regulatory strategy — including IND development, FDA meeting strategy, and approval pathways — and to represent the organization credibly in discussions with potential and existing clients. Internally, the Manager guides teams through regulatory decision-making, anticipates FDA engagement needs, and ensures regulatory deliverables meet the highest standards of quality and compliance.
Beyond strategic advising, the Manager oversees regulatory operations to ensure submissions are well-organized, on schedule, and audit-ready, and supports the growth and performance of assigned employees.
Responsibilities:
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
CONNECT WITH US!
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
Manager, Regulatory Affairs
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Manager, Regulatory Affairs is a regulatory strategy leader who advises both internal teams and external clients, bringing deep regulatory expertise to navigate complex development pathways and facilitate productive dialogue with FDA. This role combines strategic advisory skill with people leadership, managing and developing a small team of Regulatory Affairs professionals while remaining hands-on with the technical and operational work that underpins sound regulatory strategy.
The Manager acts as a trusted partner in client-facing conversations, bringing the regulatory depth and confidence needed to speak knowledgeably on US regulatory strategy — including IND development, FDA meeting strategy, and approval pathways — and to represent the organization credibly in discussions with potential and existing clients. Internally, the Manager guides teams through regulatory decision-making, anticipates FDA engagement needs, and ensures regulatory deliverables meet the highest standards of quality and compliance.
Beyond strategic advising, the Manager oversees regulatory operations to ensure submissions are well-organized, on schedule, and audit-ready, and supports the growth and performance of assigned employees.
Responsibilities:
- Regulatory & Project Leadership
- Lead regulatory activities for assigned clinical development programs, studies, or client projects.
- Develop, implement, and oversee regulatory strategies aligned with study objectives, development plans, and applicable regulatory requirements.
- Provide expert regulatory guidance regarding clinical trial applications, submissions, amendments, notifications, and other regulatory documentation.
- Oversee the preparation, review, coordination, and submission of regulatory packages to regulatory authorities and ethics committees/IRBs, as applicable.
- Interpret and apply relevant global and regional regulatory requirements, including FDA, EMA, MHRA, ICH, EU CTR, and applicable country-specific regulations.
- Serve as a regulatory subject matter expert for assigned programs and provide guidance to cross-functional project teams.
- Identify regulatory risks and issues and develop appropriate mitigation strategies.
- Ensure regulatory activities and deliverables are completed accurately, compliantly, and within established timelines.
- Support regulatory authority interactions and responses to regulatory questions and requests for information.
- Partner with Clinical Operations, Study Start-Up, Quality, Safety/Pharmacovigilance, Medical, and other functions to ensure regulatory alignment.
- Support client meetings, proposal development, bid defenses, audits, and regulatory inspections, as required.
- Critically review and provide input on protocols, ICFs, initial IND/pIND/IDE applications, CSRs, PK reports, annual IND reports, 510(K), and responses to information requests from regulatory agencies.
- Participate in regular meetings with the collaborators, sponsors. and FDA
- Participate in protocol team calls, as necessary
- Develops TOROs and related agreements
- Make submissions to Canadian health authorities
-
People Management
- Provide direct supervision and leadership to of up to 10 Regulatory Affairs employees.
- Establish goals and expectations and provide ongoing coaching, feedback, and development support.
- Conduct performance discussions and contribute to performance evaluations, compensation recommendations, and talent-development decisions.
- Support employee onboarding, training, career development, and succession planning.
- Allocate work and monitor employee workloads, priorities, quality, and delivery.
- Provide technical and professional guidance to team members and support resolution of complex regulatory issues.
- Foster collaboration, accountability, continuous learning, and consistent regulatory practices across the team.
- Participate in recruitment, interviewing, and selection activities as needed.
-
Operational Leadership
- Support the development and continuous improvement of regulatory department processes, procedures, templates, systems, and best practices.
- Monitor team capacity and resource requirements and escalate potential staffing or delivery risks.
- Support consistent application of regulatory standards and quality expectations across projects.
- Monitor regulatory trends and changes and communicate relevant implications to employees, project teams, and leadership.
- Contribute to departmental objectives and initiatives in partnership with senior Regulatory Affairs leadership.
- Performs other duties as assigned
- Complies with all policies and standards
- Bachelor's degree in life sciences, pharmacy, healthcare, or a related field; advanced degree preferred.
- Typically, 6–8+ years of relevant Regulatory Affairs experience within a CRO, pharmaceutical, biotechnology, or clinical research environment.
- 1-3 years management experience
- Demonstrated experience independently managing complex regulatory activities and submissions.
- Experience in U.S. government-funded research networks is a plus
- Prior experience leading, mentoring, or supervising regulatory professionals; formal people-management experience preferred.
- Strong knowledge of applicable global clinical research and regulatory requirements.
- Demonstrated ability to balance technical regulatory responsibilities with employee leadership and resource management.
- Strong leadership, project management, analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills.
- Ability to effectively manage competing priorities within a fast-paced, global environment.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
Flexible Approved Time Off
Tuition Reimbursement
401k Retirement Plan
Work From Home Anywhere in the US
Maternal/Paternal Leave
Casual Dress Code & Work Environment
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
Visit our website:https://www.theemmesgroup.com/
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
The Emmes Company, LLC
Manager Regulatory Affairs
Rockville, Maryland
Added 1d ago201-500 employees
Job functions:
Remote (US)
Bachelor's degree
Job Description
Overview:
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Manager, Regulatory Affairs is a regulatory strategy leader who advises both internal teams and external clients, bringing deep regulatory expertise to navigate complex development pathways and facilitate productive dialogue with FDA. This role combines strategic advisory skill with people leadership, managing and developing a small team of Regulatory Affairs professionals while remaining hands-on with the technical and operational work that underpins sound regulatory strategy.
The Manager acts as a trusted partner in client-facing conversations, bringing the regulatory depth and confidence needed to speak knowledgeably on US regulatory strategy — including IND development, FDA meeting strategy, and approval pathways — and to represent the organization credibly in discussions with potential and existing clients. Internally, the Manager guides teams through regulatory decision-making, anticipates FDA engagement needs, and ensures regulatory deliverables meet the highest standards of quality and compliance.
Beyond strategic advising, the Manager oversees regulatory operations to ensure submissions are well-organized, on schedule, and audit-ready, and supports the growth and performance of assigned employees.
Responsibilities:
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
CONNECT WITH US!
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
Manager, Regulatory Affairs
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Manager, Regulatory Affairs is a regulatory strategy leader who advises both internal teams and external clients, bringing deep regulatory expertise to navigate complex development pathways and facilitate productive dialogue with FDA. This role combines strategic advisory skill with people leadership, managing and developing a small team of Regulatory Affairs professionals while remaining hands-on with the technical and operational work that underpins sound regulatory strategy.
The Manager acts as a trusted partner in client-facing conversations, bringing the regulatory depth and confidence needed to speak knowledgeably on US regulatory strategy — including IND development, FDA meeting strategy, and approval pathways — and to represent the organization credibly in discussions with potential and existing clients. Internally, the Manager guides teams through regulatory decision-making, anticipates FDA engagement needs, and ensures regulatory deliverables meet the highest standards of quality and compliance.
Beyond strategic advising, the Manager oversees regulatory operations to ensure submissions are well-organized, on schedule, and audit-ready, and supports the growth and performance of assigned employees.
Responsibilities:
- Regulatory & Project Leadership
- Lead regulatory activities for assigned clinical development programs, studies, or client projects.
- Develop, implement, and oversee regulatory strategies aligned with study objectives, development plans, and applicable regulatory requirements.
- Provide expert regulatory guidance regarding clinical trial applications, submissions, amendments, notifications, and other regulatory documentation.
- Oversee the preparation, review, coordination, and submission of regulatory packages to regulatory authorities and ethics committees/IRBs, as applicable.
- Interpret and apply relevant global and regional regulatory requirements, including FDA, EMA, MHRA, ICH, EU CTR, and applicable country-specific regulations.
- Serve as a regulatory subject matter expert for assigned programs and provide guidance to cross-functional project teams.
- Identify regulatory risks and issues and develop appropriate mitigation strategies.
- Ensure regulatory activities and deliverables are completed accurately, compliantly, and within established timelines.
- Support regulatory authority interactions and responses to regulatory questions and requests for information.
- Partner with Clinical Operations, Study Start-Up, Quality, Safety/Pharmacovigilance, Medical, and other functions to ensure regulatory alignment.
- Support client meetings, proposal development, bid defenses, audits, and regulatory inspections, as required.
- Critically review and provide input on protocols, ICFs, initial IND/pIND/IDE applications, CSRs, PK reports, annual IND reports, 510(K), and responses to information requests from regulatory agencies.
- Participate in regular meetings with the collaborators, sponsors. and FDA
- Participate in protocol team calls, as necessary
- Develops TOROs and related agreements
- Make submissions to Canadian health authorities
-
People Management
- Provide direct supervision and leadership to of up to 10 Regulatory Affairs employees.
- Establish goals and expectations and provide ongoing coaching, feedback, and development support.
- Conduct performance discussions and contribute to performance evaluations, compensation recommendations, and talent-development decisions.
- Support employee onboarding, training, career development, and succession planning.
- Allocate work and monitor employee workloads, priorities, quality, and delivery.
- Provide technical and professional guidance to team members and support resolution of complex regulatory issues.
- Foster collaboration, accountability, continuous learning, and consistent regulatory practices across the team.
- Participate in recruitment, interviewing, and selection activities as needed.
-
Operational Leadership
- Support the development and continuous improvement of regulatory department processes, procedures, templates, systems, and best practices.
- Monitor team capacity and resource requirements and escalate potential staffing or delivery risks.
- Support consistent application of regulatory standards and quality expectations across projects.
- Monitor regulatory trends and changes and communicate relevant implications to employees, project teams, and leadership.
- Contribute to departmental objectives and initiatives in partnership with senior Regulatory Affairs leadership.
- Performs other duties as assigned
- Complies with all policies and standards
- Bachelor's degree in life sciences, pharmacy, healthcare, or a related field; advanced degree preferred.
- Typically, 6–8+ years of relevant Regulatory Affairs experience within a CRO, pharmaceutical, biotechnology, or clinical research environment.
- 1-3 years management experience
- Demonstrated experience independently managing complex regulatory activities and submissions.
- Experience in U.S. government-funded research networks is a plus
- Prior experience leading, mentoring, or supervising regulatory professionals; formal people-management experience preferred.
- Strong knowledge of applicable global clinical research and regulatory requirements.
- Demonstrated ability to balance technical regulatory responsibilities with employee leadership and resource management.
- Strong leadership, project management, analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills.
- Ability to effectively manage competing priorities within a fast-paced, global environment.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
Flexible Approved Time Off
Tuition Reimbursement
401k Retirement Plan
Work From Home Anywhere in the US
Maternal/Paternal Leave
Casual Dress Code & Work Environment
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
Visit our website:https://www.theemmesgroup.com/
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
See All 16 Regulatory Affairs Analyst Jobs in Maryland
Find roles in Maryland that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Analyst Jobs by City in Maryland
Where Maryland roles are concentrated, by current openings.
Baltimore
3 jobsFrederick
2 jobsRockville
2 jobsGermantown
2 jobsFort Detrick
2 jobsGaithersburg
2 jobsSparks
1 jobBethesda
1 jobColumbia
1 jobRegulatory Affairs Analyst Job Market in Maryland
A snapshot from current Maryland openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Human Resources
What Maryland Employers Look For
The qualifications that appear most often in regulatory affairs analyst jobs across Maryland.
- Bachelor's degree in life sciences, chemistry, engineering, or a related technical field
- Experience preparing regulatory submissions such as INDs, NDAs, or 510(k) applications
- Familiarity with FDA regulations and guidance documents governing drugs or medical devices
- Proficiency with regulatory information management systems and electronic submission tools
- Strong technical writing skills for compiling dossiers, SOPs, and compliance reports
- RAC certification from the Regulatory Affairs Professionals Society preferred for senior roles
Regulatory Affairs Analyst Jobs in Maryland: Frequently Asked Questions
How do you become a regulatory affairs analyst in Maryland?
Most Maryland employers require a bachelor's degree in a life science, engineering, or a related technical field as the foundation for this role. Maryland does not issue a state-specific license for regulatory affairs analysts, but the Regulatory Affairs Professionals Society offers the RAC credential, which Maryland-area employers in pharma and medical devices treat as a meaningful professional standard. Building experience through FDA-facing work, internships with biotech or device companies in the Baltimore or Rockville corridor, and coursework in regulatory science accelerates hiring.
Which companies hire regulatory affairs analysts in Maryland?
Companies currently hiring regulatory affairs analysts in Maryland include Precigen, AstraZeneca, and Miltenyi Biotec, per current listings on Migrate Mate as of September 2026. Maryland's proximity to FDA headquarters in Silver Spring makes the state a particularly active market for analysts supporting pharmaceutical, biologics, and medical device regulatory programs.
Which Maryland cities have the most regulatory affairs analyst jobs?
Baltimore, Frederick, and Rockville account for the largest share of regulatory affairs analyst openings in Maryland. Baltimore anchors the market through its major hospital systems, biotech firms, and university research institutions, while Rockville and Silver Spring draw heavily from their proximity to FDA headquarters and the dense concentration of pharmaceutical and biotech contractors established along the I-270 technology corridor.
Are there remote regulatory affairs analyst jobs in Maryland?
Yes, and more than most fields. About 100% of regulatory affairs analyst openings tied to Maryland are remote or hybrid as of September 2026, reflecting the desk-based and document-intensive nature of the work. Submission writing, regulatory strategy, and compliance review are among the functions most commonly offered in fully remote or hybrid arrangements, while roles requiring direct lab coordination or on-site agency interactions tend to remain in person.
How can I get hired as a regulatory affairs analyst in Maryland with little or no experience?
The most realistic entry path is applying for a regulatory affairs associate or regulatory coordinator role at one of Maryland's many biotech or pharmaceutical companies, particularly those clustered in the Baltimore and Rockville areas. Large employers and contract research organizations operating in the state often bring on recent graduates with life science or chemistry degrees for document control, submission support, or quality assurance functions that feed directly into regulatory analyst responsibilities. Earning the RAC-Associate credential or completing a regulatory affairs certificate program at a Maryland university strengthens an entry-level application considerably.
Where can I find and apply to regulatory affairs analyst jobs in Maryland?
You can find and apply to regulatory affairs analyst jobs in Maryland on Migrate Mate, which lists current openings across the state. Search the listings to identify roles that match your background and experience level, then apply directly to the ones that fit. No sign-up is required to view and apply to positions.
See All 16 Regulatory Affairs Analyst Jobs in Maryland
Find roles in Maryland that match your experience and apply in just a few clicks.
Find Jobs