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Regulatory Affairs Specialist
- Overview
We are seeking experienced Regulatory Affairs Specialists to support pharmaceutical, biotechnology, and medical device organizations operating in cGMP-regulated environments. This role focuses on ensuring products and processes meet all applicable regulatory requirements while supporting submissions, compliance, and lifecycle management.
Key Responsibilities
Prepare, review, and support regulatory submissions (e.g., IND, NDA, ANDA, BLA, 510(k), or global equivalents)
Ensure compliance with FDA, cGMP, and international regulatory standards
Maintain and update regulatory documentation and dossiers
Support product lifecycle management, including labeling changes and post-market activities
Collaborate with quality, clinical, manufacturing, and R&D teams
Monitor and interpret regulatory guidelines and changes
Assist with regulatory strategy and submission planning
Support audits, inspections, and agency interactions
Qualifications
Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field
3+ years of regulatory affairs experience in pharma, biotech, or medical device industry
Strong understanding of FDA regulations and cGMP requirements
Experience with regulatory submissions and documentation
Excellent written and verbal communication skills
Ability to manage multiple projects and deadlines
Preferred Experience
Experience with global regulatory submissions (EMA, ICH guidelines, etc.)
Background supporting early-stage or commercial products
Familiarity with eCTD submissions and regulatory systems
Experience in labeling, CMC, or clinical regulatory support
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