Role OverviewWe are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities to ensure compliance with applicable laws, regulations, and guidelines.
What You Will Do
Collaborate cross-functionally with internal teams to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, briefing books, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
Why It Might Be a Fit
The successful candidate will have experience in, and enthusiasm for, working in a small, dynamic environment with broad responsibilities, and will contribute to and help implement regulatory strategy, prepare and manage regulatory submissions, and help guide the company through complex regulatory landscapes.
Requirements
- Bachelor's degree in life sciences, pharmacy, or a related field
- Minimum of 8+ years of regulatory affairs experience within the biopharmaceutical industry
- Experience with global regulatory requirements and guidelines (including FDA, EMA, and ICH) across preclinical and clinical stages
- Working knowledge of drug laws, regulations, guidelines, and product lifecycle management
- Excellent communication and interpersonal skills
- Experience supporting or managing regulatory inspections, audits, and interactions with regulatory agencies
- Experience contributing to or executing regulatory strategies for complex products or therapies
Benefits
- Regulatory Affairs experience within the biopharmaceutical industry
- Global regulatory requirements and guidelines experience
- Working knowledge of drug laws, regulations, guidelines, and product lifecycle management
- Excellent communication and interpersonal skills
- Experience supporting or managing regulatory inspections, audits, and interactions with regulatory agencies
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