[Remote] Specialist, Regulatory Affairs - CMC - Remote

Note: The job is a remote job and is open to candidates in USA. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. The Specialist, Regulatory Affairs - CMC will be responsible for Regulatory Affairs activities for assigned commercial and investigational development products from preclinical candidate designation through product approval, including regulatory submissions.ResponsibilitiesServes as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirementsReviews proposed CMC changes and assesses regulatory impact and filing requirementsSupports the preparation, submission, and management of regulatory filings (INDs, CTAs, BLAs, etc.) to health authoritiesCollaborates on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, annual reports)Ensures timely preparation of organized and scientifically valid applicationsContributes to the development of internal regulatory CMC guidance and SOPsReviews/contributes to product development plans for assigned submissions/productsInteracts with regulatory agencies on defined mattersResponsible for executing regulatory documentation infrastructure, including paper and electronic submissionsMay be required to travel up to 15%SkillsMinimum of a Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or related fieldMust be Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook)0-2 years of experience in Regulatory AffairsStrong written and verbal communication, organizational, and people skillsDemonstrate strong analytical, problem-solving skills, and attention to detailAbility to work cross-functionally and manage multiple projects simultaneouslyRegulatory Affairs Certification or equivalent trainingExperience in pharmaceutical Regulatory Affairs with a focus in drugs/biologicsExperience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD formatKnowledge of US, EU, Health Canada, and ICH regulatory requirementsExperience directly interfacing with regulatory authoritiesBenefitsCompetitive Compensation including base salary and annual performance bonus.Flexible PTO, holidays, and parental leave.Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!Company OverviewWe believe that science-powered innovation creates possibilities. It was founded in 2002, and is headquartered in Newark, California, USA, with a workforce of 1001-5000 employees. Its website is http://www.revance.com.Company H1B SponsorshipRevance has a track record of offering H1B sponsorships, with 12 in 2025, 16 in 2024, 8 in 2023, 10 in 2022, 16 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.



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