The posting
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, 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.
