Regulatory Affairs Associate

Galderma S.A.; Boston (MA); On-site; USD 91,000 - 114,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan with employer match

Paid time off

Job summary

Galderma S.A. in the United States is seeking a Regulatory Affairs Associate to support regulatory programs across pharmaceuticals, biologics, chemical drugs, and medical devices.

You will coordinate health authority submissions and help maintain compliant documentation. Under moderate supervision, you will manage routine projects, contribute to process improvements, and provide junior-level support for regulatory review and promotional material submissions.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Pharmacy, Life Sciences, or a related field.
• 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, OTC, cosmetic, and medical device US Advertising and Promotional requirements.

Responsibilities

• Build strong, collaborative relationships with internal stakeholders and provide compliant, practical solutions.
• Provide technical guidance to line managers and other colleagues.
• Prepare and deliver presentations to business partners or leadership teams to communicate regulatory updates and initiatives.
• Regulatory Operations and Submissions: support administration and implementation of Regulatory Affairs programs and policies across product categories.
• Prepare, review, submit, track and follow up on health authority filings and related regulatory documentation.
• Gather, analyze, and summarize data from multiple sources to support submissions and regulatory reports.

Skills

Regulatory affairs

Technical writing

Communication

Regulatory submissions

Education

Bachelor’s degree in Regulatory Affairs, Pharmacy, Life Sciences, or related field

Tools

Regulatory IM Systems

MS Office

Job description

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our 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, analyse and summarise 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 escalat e 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 organisational 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 organisational 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 within 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 programme, subject to plan terms and eligibility requirements.

Benefits

Galderma offers a competitive and comprehensive benefits programme, 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 organisation 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.

Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.

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.

For more information go to www.galderma.com/careers

If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers.