San Francisco Bay Area
Competitive - Above Market Average
BD - 375
27 days ago
Manager, Regulatory Affairs
Location: San Francisco
**also have similar roles in LA & the San Diego Area
Type: Full Time Permanent
Salary: Excellent salary, bonus, equity and accompanying benefits package (will relocate)
This Bay Area Biopharmaceutical is one of the hottest companies in the oncology market and is looking for a Manager/Senior Manager to work on early to late stage oncology/rare disase development products. This is a new role purely based on pipeline advancement and increased workloads.This vacancy provides excellent upwards mobility within the company and the ability to work with some of the brightest leaders in drug development in the Bay area!
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 3-6 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 email@example.com