Associate Director of Regulatory Affairs Jobs
Associate Director of Regulatory Affairs jobs are open across pharmaceuticals, biotechnology, medical devices, and consumer health, from manager-level to VP, with specializations in drug development, clinical submissions, and CMC regulatory strategy. See the openings below and apply to the ones that match your experience.
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Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
The Opportunity
The Regulatory Affairs Associate supports and implements Regulatory Affairs programs, processes, and policies to support regulatory activities for pharmaceuticals, biologics, chemical drugs, and medical devices. This role coordinates recurring regulatory activities, supports health authority submissions, maintains accurate regulatory documentation and contributes to Drugs CMC regulatory, regulatory operations, and scientific and medical writing.
Working with moderate supervision, the Regulatory Affairs Associate manages routine projects, resolves operational issues and contributes to process improvements including the improvement of regulatory workflows and ensuring timely, accurate submissions. This role also provides junior-level support for the regulatory review of pharmaceutical, biologic, medical device, cosmetic and over the counter products and submission of promotional materials at time of first use.
Key Responsibilities
- Build strong, collaborative relationships with internal stakeholders, understanding their needs and providing compliant, practical solutions.
- Provide technical guidance to line managers and other colleagues. Prepare and deliver presentations to business partners or leadership team to communicate regulatory updates and initiatives.
Regulatory Operations and Submissions
- Support the administration and Implement of Regulatory Affairs programs, processes, and policies to support regulatory compliance across product categories.
- Prepare, review, submit, track and follow up on health authority filings and related regulatory documentation.
- Maintain and archive registration files in accordance with applicable procedures and record-retention requirements.
- Gather, compile, analyze and summarize data from multiple sources to support submissions, regulatory reports and compliance documentation.
- Support CMC regulatory, regulatory operations and medical-writing activities.
- Identify operational issues, interpret applicable procedures, and escalate complex matters appropriately.
- Contribute to the design and improvement of regulatory workflows, templates, tracking tools and quality controls.
Scientific and Medical Documentation
- Draft, edit, format, and review scientific summaries, manuscripts, clinical study reports, monographs, presentations, and other regulatory documents.
- Prepare literature for new products and revise existing product materials.
- Conduct literature searches and maintains files of journal articles and abstracts for current and anticipated business needs.
Advertising and Promotion
- Review derivative materials and second/third round of advertising and promotional materials under the guidance of experienced Regulatory Affairs manager and colleagues.
- Compare promotional claims, indications, intended use, safety information, and product descriptions against current approved labeling, instructions for use, and supporting evidence.
- Check claims are truthful, accurate, adequately substantiated, and not misleading.
- Escalate inconsistent claims to senior reviewers.
- Verify the inclusion, accuracy, prominence, and presentation of required safety, risk, limitation, and fair-balance information.
- Support the implementation of approved changes and verify that final materials reflect the approved review comments.
- Assist with monitoring changes in labeling, scientific evidence, and regulatory requirements that may affect active promotional materials. Support preparation of applicable advertising and promotional FDA Form 2253 submissions under supervision.
Qualifications
- Bachelor’s degree in Regulatory Affairs, Pharmacy, Life Sciences, or a related field, or equivalent experience/qualification.
- 3–7 years of experience in regulatory affairs, with exposure to biologicals, chemical drugs, and/or medical devices.
- Advanced knowledge of regulatory submission processes, documentation standards, and compliance requirements.
- Strong technical writing, editing, and document review skills for scientific and regulatory content.
- Experience with Drugs CMC regulatory processes, medical writing, and health authority submissions.
- Foundational knowledge of pharmaceutical, Over The Counter, Cosmetic and medical device US Advertising and Promotional requirements.
- Knowledge of regulatory submissions, documentation standards, product labeling and compliance processes.
- Excellent problem-solving skills, with the ability to resolve issues.
- Strong organizational skills, attention to detail, and commitment to accurate and timely work.
- Ability to manage assignments independently while escalating complex or higher risk matters.
- Strong interpersonal skills to build trust and influence across functions.
- Proficiency with regulatory information management systems and Microsoft Office Suite.
- Detail-oriented with a commitment to accuracy, compliance, and operational efficiency. Proficient in Microsoft Office Suite, Regulatory Information Management Systems, and electronic review or document-management platforms.
Physical Requirements and Work Environment
This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.
Compensation
The target base salary range for this role is $91,200-$114,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors.
In addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.
Benefits
Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and other benefits, subject to eligibility and applicable plan terms.
Work Authorization
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
What We Offer
At Galderma, you’ll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.
Next Steps
- If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager The final step is a panel conversation with the extended team
Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!
If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers . Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
The Opportunity
The Regulatory Affairs Associate supports and implements Regulatory Affairs programs, processes, and policies to support regulatory activities for pharmaceuticals, biologics, chemical drugs, and medical devices. This role coordinates recurring regulatory activities, supports health authority submissions, maintains accurate regulatory documentation and contributes to Drugs CMC regulatory, regulatory operations, and scientific and medical writing.
Working with moderate supervision, the Regulatory Affairs Associate manages routine projects, resolves operational issues and contributes to process improvements including the improvement of regulatory workflows and ensuring timely, accurate submissions. This role also provides junior-level support for the regulatory review of pharmaceutical, biologic, medical device, cosmetic and over the counter products and submission of promotional materials at time of first use.
Key Responsibilities
- Build strong, collaborative relationships with internal stakeholders, understanding their needs and providing compliant, practical solutions.
- Provide technical guidance to line managers and other colleagues. Prepare and deliver presentations to business partners or leadership team to communicate regulatory updates and initiatives.
Regulatory Operations and Submissions
- Support the administration and Implement of Regulatory Affairs programs, processes, and policies to support regulatory compliance across product categories.
- Prepare, review, submit, track and follow up on health authority filings and related regulatory documentation.
- Maintain and archive registration files in accordance with applicable procedures and record-retention requirements.
- Gather, compile, analyze and summarize data from multiple sources to support submissions, regulatory reports and compliance documentation.
- Support CMC regulatory, regulatory operations and medical-writing activities.
- Identify operational issues, interpret applicable procedures, and escalate complex matters appropriately.
- Contribute to the design and improvement of regulatory workflows, templates, tracking tools and quality controls.
Scientific and Medical Documentation
- Draft, edit, format, and review scientific summaries, manuscripts, clinical study reports, monographs, presentations, and other regulatory documents.
- Prepare literature for new products and revise existing product materials.
- Conduct literature searches and maintains files of journal articles and abstracts for current and anticipated business needs.
Advertising and Promotion
- Review derivative materials and second/third round of advertising and promotional materials under the guidance of experienced Regulatory Affairs manager and colleagues.
- Compare promotional claims, indications, intended use, safety information, and product descriptions against current approved labeling, instructions for use, and supporting evidence.
- Check claims are truthful, accurate, adequately substantiated, and not misleading.
- Escalate inconsistent claims to senior reviewers.
- Verify the inclusion, accuracy, prominence, and presentation of required safety, risk, limitation, and fair-balance information.
- Support the implementation of approved changes and verify that final materials reflect the approved review comments.
- Assist with monitoring changes in labeling, scientific evidence, and regulatory requirements that may affect active promotional materials. Support preparation of applicable advertising and promotional FDA Form 2253 submissions under supervision.
Qualifications
- Bachelor’s degree in Regulatory Affairs, Pharmacy, Life Sciences, or a related field, or equivalent experience/qualification.
- 3–7 years of experience in regulatory affairs, with exposure to biologicals, chemical drugs, and/or medical devices.
- Advanced knowledge of regulatory submission processes, documentation standards, and compliance requirements.
- Strong technical writing, editing, and document review skills for scientific and regulatory content.
- Experience with Drugs CMC regulatory processes, medical writing, and health authority submissions.
- Foundational knowledge of pharmaceutical, Over The Counter, Cosmetic and medical device US Advertising and Promotional requirements.
- Knowledge of regulatory submissions, documentation standards, product labeling and compliance processes.
- Excellent problem-solving skills, with the ability to resolve issues.
- Strong organizational skills, attention to detail, and commitment to accurate and timely work.
- Ability to manage assignments independently while escalating complex or higher risk matters.
- Strong interpersonal skills to build trust and influence across functions.
- Proficiency with regulatory information management systems and Microsoft Office Suite.
- Detail-oriented with a commitment to accuracy, compliance, and operational efficiency. Proficient in Microsoft Office Suite, Regulatory Information Management Systems, and electronic review or document-management platforms.
Physical Requirements and Work Environment
This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.
Compensation
The target base salary range for this role is $91,200-$114,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors.
In addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.
Benefits
Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and other benefits, subject to eligibility and applicable plan terms.
Work Authorization
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
What We Offer
At Galderma, you’ll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.
Next Steps
- If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager The final step is a panel conversation with the extended team
Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!
If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers . Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.
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Find JobsAssociate Director of Regulatory Affairs Job Market
Who's Hiring
- Katalyst Healthcares & Life Sciences49
- AbbVie21
- Revolution Medicines18
- BD10
- Abbott10
Top Industries Hiring
- Biotechnology & Pharmaceuticals58
- Medical Devices13
- Healthcare & Medical Services11
- Consulting & Professional Services9
- Science & Research4
What Employers Look For
The qualifications that appear most often in associate director of regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- Minimum five to eight years of regulatory affairs experience in pharmaceutical or biotech settings
- Hands-on experience preparing and submitting INDs, NDAs, BLAs, or 510(k)s to the FDA
- Working knowledge of ICH guidelines, 21 CFR regulations, and eCTD submission standards
- RAC certification from the Regulatory Affairs Professionals Society preferred or required
- Experience using regulatory information management systems such as Veeva Vault or similar platforms
Tips for Your Associate Director of Regulatory Affairs Job Search
Align your resume to submission types
Hiring managers scan for specific submission experience like INDs, NDAs, BLAs, or 510(k)s. Call these out explicitly in your resume summary and experience bullets rather than burying them in a skills list or leaving reviewers to infer them.
Highlight agency interaction experience
Direct FDA meeting experience, type A, B, or C meetings, or EMA interactions, signals seniority that separates you from candidates who have only supported submissions. If you've led agency briefing documents or response strategies, say so explicitly.
Apply early to roles that fit
Migrate Mate lists associate director of regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Target postings by regulatory pathway
Filter openings by the pathway that matches your background, whether that's small molecule, biologics, combination products, or OTC. Applying to roles outside your pathway without addressing the gap in your cover letter is a common reason strong candidates are screened out early.
Prepare for a regulatory strategy case interview
Many employers at this level give a take-home scenario or live case, asking how you'd handle an unexpected FDA information request or a CMC deficiency letter. Practice articulating your decision-making process out loud, not just your technical answer.
Negotiate scope before you negotiate salary
At the associate director level, the team size you'll manage, the therapeutic areas you'll own, and whether you'll have direct agency contact matter as much as compensation. Clarify these before accepting an offer to avoid a mismatch in your first 90 days.
Associate Director of Regulatory Affairs Jobs: Frequently Asked Questions
Which companies are hiring the most associate director of regulatory affairss?
The most active employers for associate director of regulatory affairss right now are Katalyst Healthcares & Life Sciences, AbbVie, and Revolution Medicines, and the most openings are in California, Massachusetts, and New Jersey, based on current listings on Migrate Mate as of November 2026. Demand is concentrated at mid-size biotechs and large pharma companies with active late-stage pipelines.
How many associate director of regulatory affairs jobs are remote?
About 73% of associate director of regulatory affairs openings are fully remote or hybrid as of November 2026, with remote availability highest for roles focused on submissions writing, regulatory strategy, and labeling review. Positions that require direct oversight of on-site manufacturing documentation or frequent in-person agency meetings are more likely to require a local presence.
How do you become a associate director of regulatory affairs?
Start with a degree in life sciences, pharmacy, or a closely related field, then build hands-on experience in regulatory submissions or compliance at a pharmaceutical, biotech, or medical device company. Earning the RAC credential demonstrates formal regulatory knowledge to employers. Progress typically moves through specialist and manager roles before reaching associate director, with each step adding depth in a specific submission type, therapeutic area, or regulatory region.
How do you get hired as an associate director of regulatory affairs with limited experience?
Focus on roles where your submission experience is directly relevant even if your seniority is lighter, since employers weight hands-on IND, NDA, or 510(k) work heavily at this level. Contract or consulting regulatory roles can accelerate your exposure to full submission cycles. Targeting smaller biotechs, which often promote from within faster than large pharma, is another practical path when you're one level below the typical experience threshold.
What does the associate director of regulatory affairs interview process look like?
The process typically starts with a recruiter screen, followed by a technical interview with the regulatory affairs leadership team focused on your submission history and agency interaction experience. Many companies add a written or verbal case exercise where you work through a realistic regulatory scenario. Final rounds often include cross-functional stakeholders from clinical, CMC, or medical affairs, since the role requires close collaboration across those groups.
Where can I find and apply to associate director of regulatory affairs jobs?
You can find and apply to associate director of regulatory affairs jobs on Migrate Mate, which lists current openings from across the United States. Search for roles that match your submission background, therapeutic area, and geographic preference, then apply directly to each listing that fits your experience.
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Find roles that match your experience and apply in just a few clicks.
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