San Francisco, California
Competitive - Above Market Average
BD - 210
about 1 month ago
Manager, Regulatory Affairs
Location: San Francisco
**also have similar roles in LA & the Bay Area
Type: Full Time Permanent
Salary: Excellent salary, bonus, equity and accompanying benefits package
This Bay Area biopharmaceutical is well funded, recently commercialized and continuing to develop novel medicines in several indications for patients with cancer. cxcellent upwards mobility within the company and the ability to work on early development to late stage products with some of the best Regulatory Affairs professionals in drug development.
The Manager will support the regulatory leads on clinical oncology programs, contributing to the development and implementation of regulatory strategy, development of supporting regulatory documents, and serving as the regulatory contact with regulatory health authorities. The perfect candidate can thrive in a fast-paced environment and is up for a new challenge for a growing biotech.
- Responsible for coordinating regulatory Submissions
- Responsible for regulatory project management of US and EU regulatory submissions including IND/IMPD/CTA, NDA/MAA submissions, fast track and breakthrough designation requests, and orphan drug application
- Act as regulatory lead as needed to implement regulatory strategy.
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Participate and contribute in Health Authority meetings.
- BS degree required; Life/Health Sciences preferred.
- At least 2-4 years regulatory experience within Drug Development
- Strong project management skills including familiarity with PM toolkits.
- Ability to represent the department in project teams.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at 646-349-4344 or at firstname.lastname@example.org