Job Opportunity
Job Title: Director Regulatory & CMC
Location: Northern CA
Industry: Pharmaceutical
Type: Full-time
Description: Assume a key leadership role in Regulatory Affairs with broad responsibilities. Our client company is a stable, dynamic, and growing pharmaceutical company that develops a broad base of pharmaceutical products. Company employees at all levels are experienced, highly qualified team players and the company has developed an exciting, team oriented work environment. This position reports directly to the companies VP Clinical and Regulatory Affairs.
Contributions:
- Assist in the development & implementation of companies’ regulatory strategy.
- Prepare and submit INDs, ANDAs, NDAs, 510Ks, PMAs, BLAs submissions/approvals.
- Facilitate a good understanding of electronic submissions (eCTD).
- Work closely with internal Project Management, Sales, Marketing, R&D, Medical Affairs, & Legal departments as required.
- Act as the FDA liaison and obtain regulatory approvals for submissions. Build strong working relationships with the FDA.
- Hire, train, & lead Regulatory staff. Manage regulatory project distribution and workload.
- Create systems / procedures and provide technical leadership as required.
- Review and approve proposals and invoices to pharmaceutical clients. May also assist with business development as needed.
- Participate in Promotional Review Board process with Marketing, review of promotional materials, and support development of launch materials.
Capabilities:
- BS, MS or advanced degree (PhD, PharmD) in a related scientific discipline, plus training in regulatory affairs.
- 10+ years pharmaceutical and/or device industry experience with emphasis on regulatory affairs, CMC, and drug development.
- 5+ years experience in pharmaceutical industry management roles.
- Must be experienced in preparing / reviewing regulatory submissions.
- Solid track record of experience reviewing promotional materials and interfacing with the FDA DDMAC.
- Effective leadership, organization, project management, & communication skills with strong emphasis on quality and accuracy of work.
- Collaborative team player that can establish & maintain effective working relationships with other departments, the FDA, and pharmaceutical clients.
Contact: infomrb@mrbellevue.com
If this opportunity does not meet your needs but you know someone qualified, please refer this opportunity to them. Refer This Opportunity to a Colleague.