Regulatory Affairs Specialist

Job Summary

We 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 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

Required Qualifications

• 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