Regulatory Affairs Analyst Jobs
Regulatory Affairs Analyst jobs are open across pharmaceuticals, medical devices, biotechnology, food and beverage, and consumer products, covering specializations in submissions management, compliance monitoring, and labeling review, from entry-level associate to senior and principal analyst. Find a role that fits below and apply directly.
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Job Summary
The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule and biological/biotechnological products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include EU/UK/CH and secondarily US/ Canada for smooth, timely approvals or continued marketing.
Job Description
Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., MAA/NDA), and post-approval lifecycle activities (extensions/ variations/supplements,) for drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (EMA, FDA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements.
Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters.
Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy).
Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products.
Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late stage product development as well as post approval changes.
Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
.
Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Trackwise Digital (Quality Management System), eCTS Viewer, Adobe Acrobat, and Microsoft Office tools.
Performs other duties as assigned related to CMC RA function.
Qualifications
Education :
BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline
Experience :
7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products.
Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead
Regulatory experience in handling-controlled substance applications will be a plus
Skills:
Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues.
Knowledge of CMC regulatory requirements during late stage development, initial marketing application and post-approval.
Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND/IMPD/NDA/MAA/ASMF/CEP, post-approval variations) for EMA, UK, CH and equivalent submissions for US and Canada.
Comprehensive understanding of the global regulatory environment
Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines.
Strong leadership, communication, and negotiation skills.
Ability to manage complex projects and timelines across multiple regions.
Computer skills with demonstrated experience in working with the Microsoft suite of programs (Teams; Sharepoint; Word; Excel; PowerPoint; Outlook).
CMC reviewer (assessor) with EMA, EU or UK regulatory agencies or FDA will be a benefit
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Application Deadline : This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic .
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request .
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Job Summary
The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule and biological/biotechnological products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include EU/UK/CH and secondarily US/ Canada for smooth, timely approvals or continued marketing.
Job Description
Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., MAA/NDA), and post-approval lifecycle activities (extensions/ variations/supplements,) for drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (EMA, FDA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements.
Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters.
Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy).
Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products.
Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late stage product development as well as post approval changes.
Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
.
Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Trackwise Digital (Quality Management System), eCTS Viewer, Adobe Acrobat, and Microsoft Office tools.
Performs other duties as assigned related to CMC RA function.
Qualifications
Education :
BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline
Experience :
7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products.
Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead
Regulatory experience in handling-controlled substance applications will be a plus
Skills:
Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues.
Knowledge of CMC regulatory requirements during late stage development, initial marketing application and post-approval.
Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND/IMPD/NDA/MAA/ASMF/CEP, post-approval variations) for EMA, UK, CH and equivalent submissions for US and Canada.
Comprehensive understanding of the global regulatory environment
Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines.
Strong leadership, communication, and negotiation skills.
Ability to manage complex projects and timelines across multiple regions.
Computer skills with demonstrated experience in working with the Microsoft suite of programs (Teams; Sharepoint; Word; Excel; PowerPoint; Outlook).
CMC reviewer (assessor) with EMA, EU or UK regulatory agencies or FDA will be a benefit
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Application Deadline : This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic .
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request .
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Regulatory Affairs Analyst Jobs by Experience Level
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Find JobsRegulatory Affairs Analyst Job Market
Who's Hiring
- Revolution Medicines21
- Abbott17
- Dentsply Sirona15
- AbbVie14
- Oscar Health10
Top Industries Hiring
- Biotechnology & Pharmaceuticals136
- Medical Devices45
- Healthcare & Medical Services30
- Technology & Software16
- Manufacturing14
What Employers Look For
The qualifications that appear most often in regulatory affairs analyst jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related scientific field
- Experience preparing and submitting regulatory filings such as 510(k)s, INDs, or NDAs
- Working knowledge of FDA regulations, guidance documents, and quality system requirements
- Familiarity with document management systems and electronic submission platforms
- Strong technical writing skills for authoring regulatory submissions and SOPs
- RAC certification from RAPS preferred or required for senior-level positions
Tips for Your Regulatory Affairs Analyst Job Search
Tailor your resume to submission types
Regulatory affairs roles differ sharply between 510(k) submissions, INDs, NDAs, and BLAs. Call out the exact submission types you've worked on by name in your resume bullet points so hiring managers know you're not starting from scratch.
Apply early to roles that fit
Migrate Mate lists regulatory affairs analyst openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Highlight your agency interaction experience
Candidates who have authored responses to FDA deficiency letters or managed pre-submission meetings stand out. If you've had any direct correspondence with a regulatory body, name it explicitly on your resume rather than burying it in a general responsibilities list.
Target job postings by product classification
Regulatory work for a Class III implantable device looks nothing like work for an OTC drug or a dietary supplement. Search by product type, not just job title, so you're targeting openings where your specific regulatory pathway experience actually transfers.
Prepare a case study answer about a real submission
Interviewers in regulatory affairs routinely ask you to walk through a submission from gap analysis to filing. Practice a two-minute answer built around a real project you owned, focusing on how you resolved a specific technical or labeling challenge.
Negotiate using your RAC or RAPS membership
Active membership in RAPS and a current RAC certification signal ongoing professional development, which many employers treat as a proxy for up-to-date regulatory knowledge. Bring both up explicitly during offer discussions, especially if a competing candidate lacks them.
Regulatory Affairs Analyst Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory affairs analysts?
The most active employers for regulatory affairs analysts right now are Revolution Medicines, Abbott, and Dentsply Sirona, and the most openings are in California, Massachusetts, and New Jersey, based on current listings on Migrate Mate as of July 2026. Demand tends to be highest at medical device manufacturers, pharmaceutical companies, and contract research organizations managing active product pipelines.
How many regulatory affairs analyst jobs are remote?
About 53% of regulatory affairs analyst openings are fully remote or hybrid as of July 2026, with availability varying by company size and product type. Roles focused on document review, submissions writing, and labeling compliance are more likely to be remote, while positions requiring hands-on quality system audits or lab coordination tend to require on-site presence.
How do you become a regulatory affairs analyst?
Start with a bachelor's degree in a life science, chemistry, pharmacy, or engineering discipline, since most employers treat a scientific foundation as non-negotiable. Build exposure to regulatory frameworks early through internships, quality assurance roles, or research positions that touch documentation and compliance. Earning the RAC credential from RAPS strengthens your candidacy once you have some foundational experience in place.
Can you get a regulatory affairs analyst job with little experience?
Yes, entry-level regulatory affairs analyst roles exist, but you need to show relevant adjacent experience rather than a blank slate. Internships in quality assurance, clinical operations, or research documentation translate well. Emphasize any work involving SOPs, gap analyses, or document control, and complete a RAPS fundamentals course to signal you understand the regulatory landscape before your first interview.
What does the regulatory affairs analyst interview process look like?
Most processes begin with a recruiter screening call focused on your scientific background and submission experience, followed by a technical interview with a regulatory affairs manager or director who will ask you to walk through a past submission or regulatory challenge. Some employers add a writing exercise asking you to draft or review a section of a regulatory document, and the final round typically includes a panel with cross-functional stakeholders from R&D or quality.
Where can I find and apply to regulatory affairs analyst jobs?
You can find and apply to regulatory affairs analyst jobs on Migrate Mate, which lists current openings from across the United States. Search for roles that match your background in pharmaceuticals, medical devices, biotechnology, or consumer products, and apply directly to each listing that fits your experience and location preferences.
See All 676+ Regulatory Affairs Analyst Jobs
Find roles that match your experience and apply in just a few clicks.
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