Regulatory Affairs Specialist

Job Title: Regulatory Affairs SpecialistLocations: New Jersey, Pennsylvania, Massachusetts, Connecticut, Rhode Island, Salt Lake City (UT), CaliforniaDuration: Long Term contractJob SummaryWe are seeking experienced Regulatory Affairs professionals to support regulatory strategy, submissions, and compliance activities across pharmaceutical, biotechnology, and medical device programs. This role will work closely with cross-functional teams to ensure products meet global regulatory requirements throughout development, approval, and commercialization.The ideal candidate will have strong experience with FDA regulations, regulatory submissions, and lifecycle management activities in regulated environments.Key ResponsibilitiesPrepare, review, and support regulatory submissions including INDs, NDAs, BLAs, 510(k)s, PMAs, amendments, supplements, and annual reportsDevelop and execute regulatory strategies to support product development and commercializationEnsure compliance with FDA, EMA, ICH, and global regulatory requirementsCollaborate with Quality, Clinical, R&D, Manufacturing, and CMC teams on regulatory activitiesSupport change control assessments, labeling updates, and product lifecycle managementReview technical documentation, SOPs, and regulatory filings for accuracy and complianceSupport regulatory inspections, audits, and agency interactionsMonitor evolving regulatory requirements and communicate impact to internal stakeholdersRequired QualificationsBachelor s degree in Life Sciences, Pharmacy, Regulatory Affairs, Engineering, or related field3 10+ years of experience in Regulatory Affairs within pharma, biotech, or medical devicesStrong knowledge of FDA regulations and global regulatory frameworksExperience supporting regulatory submissions and compliance activitiesExcellent communication, technical writing, and project management skillsAbility to work cross-functionally in fast-paced environments