Biology, Biotech and Pharmaceutical, Change Control, Communication Skills, Cross-Functional, FDA (Food and Drug Administration), FDA Requirements, Healthcare Quality, ICH Regulations, Investigational New Drug (IND), Maintain Compliance, Manufacturing, Medical Equipment, Monitor Regulations, New Drug Application, Pharmacy, Product Development, Product Lifecycle Management, Product Support, Product/Service Launch, Project/Program Management, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Standard Operating Procedures (SOP), Technical Writing
Job Title: Regulatory Affairs Specialist
Locations: New Jersey, Pennsylvania, Massachusetts, Connecticut, Rhode Island, Salt Lake City (UT), California
Duration: Long Term contract
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
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Stark Pharma Solutions Inc