Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
Ladders · Rahway, NJ · Yesterday
On-siteLegal$210k–$331k/yrFull-time
Responsibilities
- Develop and implement global regulatory strategy for vaccine and infectious disease projects
- Serve as the primary global regulatory contact for assigned products
- Provide expert regulatory advice to Product Development Teams throughout the product lifecycle
- Lead cross-functional Global Regulatory Team supporting development programs
- Communicate with FDA and prepare teams for meetings during all drug development phases
- Cook up interactions with foreign regulatory agencies for international strategy support
- Review and approve key regulatory documents and applications prior to submission
Qualifications
- M.D., Ph.D. or equivalent doctoral degree in biological or chemical sciences
- 3+ years drug development experience for M.D. candidates; 5+ years for Ph.D.; 7+ years for M.S. candidates preferred, especially in regulatory affairs
- Excellent oral and written communication skills
- Strong organizational skills with the ability to manage multiple projects
- Flexibility and adaptability in a dynamic environment
- Exceptional scientific and analytical skills with attention to detail
- Ability to work independently with minimal supervision
Benefits
- Comprehensive medical, dental, and vision healthcare plans for employees and families
- 401(k) retirement benefits with company matching
- Paid holidays, vacation, and additional sick days
- Opportunities for annual bonuses and long-term incentives