Regulatory Affairs Specialist

About This Role

This specialist role supports regulatory strategy, submissions, and compliance activities across pharmaceutical, biotechnology, and medical device programs. The work involves close collaboration with cross-functional teams to ensure products meet global regulatory requirements throughout development, approval, and commercialization.

Responsibilities

• Prepare, review, and support regulatory submissions including INDs, NDAs, BLAs, 510(k)s, PMAs, amendments, supplements, and annual reports
• Develop and execute regulatory strategies to support product development and commercialization
• Ensure compliance with FDA, EMA, ICH, and global regulatory requirements
• Collaborate with Quality, Clinical, R&D, Manufacturing, and CMC teams on regulatory activities
• Support change control assessments, labeling updates, and product lifecycle management
• Review technical documentation, SOPs, and regulatory filings for accuracy and compliance
• Support regulatory inspections, audits, and agency interactions
• Monitor evolving regulatory requirements and communicate impact to internal stakeholders

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Engineering, or related field
• 3-10+ years of experience in Regulatory Affairs within pharma, biotech, or medical devices
• Strong knowledge of FDA regulations and global regulatory frameworks
• Experience supporting regulatory submissions and compliance activities
• Excellent communication, technical writing, and project management skills
• Ability to work cross-functionally in fast-paced environments

Important Details

• Locations: New Jersey, Pennsylvania, Massachusetts, Connecticut, Rhode Island, Salt Lake City (UT), California
• Contract: long term