Associate Director/Director – Regulatory Affairs
Job Description
- Oversee regulatory strategies, submissions, and writing for pharmaceutical products targeted for the U.S. market
- Work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance
- Provide consultation on regulatory aspects during the development phase
- Ensure all activities are planned and executed for a successful submission
- Guide products through the development pipeline and secure FDA approval Requirements
- Advanced degree in life sciences, pharmacy, or a related field
- 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
- Proven track record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA
- Experience in regulatory strategy planning for generic drugs and combination products
- Strong knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions
- Exceptional project management skills with the ability to manage multiple priorities and deadlines
- Strong analytical and problem-solving skills with a proactive and solutions-oriented mindset
- Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies.
Benefits
- Remote work options
- Professional development opportunities Apply tot his job Apply To this Job Apply tot his job Apply To this Job Apply tot his job Apply To this Job
Apply tot his job Apply To this Job