San Diego, California
about 1 month ago
Senior Manager, Regulatory Affairs
Location: San Diego, California
Type: Full Time Permanent
Salary: Excellent salary, bonus, equity and accompanying benefits package
This SoCal biotech is in serious growth mode with a strong, early clinical pipeline looking to revolutionize oncology treatments to seriously improve the lives of patients. High visibility to executive leadership with excellent upwards mobility and the ability to learn from some of the best Regulatory Affairs professionals in drug development.
The Senior Manager will support the regulatory leads on clinical 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 work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
- Ability to represent the department in project teams.
- Experience in the preparation of annual reports, DSURS, IB amendments and supplements.
- Knowledge and understanding of applicable regulations.
- 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