{"id":4046012,"url":"https://alion.io/job/galderma-regulatory-affairs-associate","title":"Regulatory Affairs Associate","company":{"id":1758178,"name":"Galderma","domain":"galderma.com","url":"https://alion.io/company/galderma-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":33,"ghost_share":0,"stale_share":0.848,"repost_share":0,"time_to_fill_p50_days":35,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":91200,"max":114000,"currency":"USD","period":"year","gross":null,"usd_annual":114000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-10T23:55:42Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-11T05:26:41Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"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.\nWe 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.\nAt 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.\nThe Opportunity\nThe 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.\nWorking 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.\nKey Responsibilities\nBuild strong, collaborative relationships with internal stakeholders, understanding their needs and providing compliant, practical solutions.\nProvide technical guidance to line managers and other colleagues.\nPrepare and deliver presentations to business partners or leadership team to communicate regulatory updates and initiatives.\nRegulatory Operations and Submissions\nSupport the administration and Implement of Regulatory Affairs programs, processes, and policies to support regulatory compliance across product categories.\nPrepare, review, submit, track and follow up on health authority filings and related regulatory documentation.\nMaintain and archive registration files in accordance with applicable procedures and record-retention requirements.\nGather, compile, analyze and summarize data from multiple sources to support submissions, regulatory reports and compliance documentation.\nSupport CMC regulatory, regulatory operations and medical-writing activities.\nIdentify operational issues, interpret applicable procedures, and escalate complex matters appropriately.\nContribute to the design and improvement of regulatory workflows, templates, tracking tools and quality controls.\nScientific and Medical Documentation\nDraft, edit, format, and review scientific summaries, manuscripts, clinical study reports, monographs, presentations, and other regulatory documents.\n Prepare literature for new products and revise existing product materials.\nConduct literature searches and maintains files of journal articles and abstracts for current and anticipated business needs.\nAdvertising and Promotion\nReview derivative materials and second/third round of advertising and promotional materials under the guidance of experienced Regulatory Affairs manager and colleagues.\nCompare promotional claims, indications, intended use, safety information, and product descriptions against current approved labeling, instructions for use, and supporting evidence.\nCheck claims are truthful, accurate, adequately substantiated, and not misleading.\nEscalate inconsistent claims to senior reviewers.\nVerify the inclusion, accuracy, prominence, and presentation of required safety, risk, limitation, and fair-balance information.\nSupport the implementation of approved changes and verify that final materials reflect the approved review comments.\nAssist with monitoring changes in labeling, scientific evidence, and regulatory requirements that may affect active promotional materials.\nSupport preparation of applicable advertising and promotional FDA Form 2253 submissions under supervision.\nQualifications\nBachelor’s degree in Regulatory Affairs, Pharmacy, Life Sciences, or a related field, or equivalent experience/qualification.\n3-7 years of experience in regulatory affairs, with exposure to biologicals, chemical drugs, and/or medical devices.\nAdvanced knowledge of regulatory submission processes, documentation standards, and compliance requirements.\nStrong technical writing, editing, and document review skills for scientific and regulatory content.\nExperience with Drugs CMC regulatory processes, medical writing, and health authority submissions.\nFoundational knowledge of pharmaceutical, Over The Counter, Cosmetic and medical device US Advertising and Promotional requirements.\nKnowledge of regulatory submissions, documentation standards, product labeling and compliance processes.\nExcellent problem-solving skills, with the ability to resolve issues.\nStrong organizational skills, attention to detail, and commitment to accurate and timely work.\nAbility to manage assignments independently while escalating complex or higher risk matters.\nStrong interpersonal skills to build trust and influence across functions.\nProficiency with regulatory information management systems and Microsoft Office Suite.\nDetail-oriented with a commitment to accuracy, compliance, and operational efficiency.\nProficient in Microsoft Office Suite, Regulatory Information Management Systems, and electronic review or document-management platforms.\nPhysical Requirements and Work Environment\nThis 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.\nThis 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.\nCompensation\nThe 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.\nIn addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.\nBenefits\nGalderma 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.\nWork Authorization\nThis role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.\nWhat We Offer\nAt 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.\nNext Steps\nIf your profile is a match, we will invite you for a first virtual conversation with the recruiter. \nThe next step is a virtual conversation with the hiring manager \nThe final step is a panel conversation with the extended team \nDon'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!\nIf 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.","description_format":"text","description_chars":9824,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Dermatology","Aesthetic Medicine & Plastic Surgery","Skincare"],"lifecycle":[{"event":"open","at":"2026-11-10T23:55:42Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":142500,"route":null,"cap_exempt":false,"checked_at":"2026-11-11T07:38:50+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":0,"expected_fill_days":35,"reasons":["conf:0","stale_co","win:early","comp:brand"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":114000,"is_top_pay":false},"html_url":"https://alion.io/job/galderma-regulatory-affairs-associate","json_url":"https://alion.io/job/galderma-regulatory-affairs-associate.json","meta":{"generated_at":"2026-11-11T13:00:18Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":23432,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1758178},"rest":"https://alion.io/mcp/rest/get_company?id=1758178"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgalderma-regulatory-affairs-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgalderma-regulatory-affairs-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgalderma-regulatory-affairs-associate"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/galderma-regulatory-affairs-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgalderma-regulatory-affairs-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4046012}},{"tool":"search_jobs","arguments":{"company":"galderma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4046012},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}