South San Francisco
Competitive - Above Market Average
BD - 230
7 months ago
Associate Director, Regulatory Affairs
Location: South San Francisco
Type: Full Time Permanent
Salary: Excellent salary, bonus, equity and accompanying benefits package. Ask about our flexible work options due to COVID-19
This Bay Area biotech is in serious growth mode with a strong, early clinical pipeline looking to revolutionize medicines in the rare disease space. The role provides 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. My clieant is an excellent financial standing and has a strong pipeline of pre-clinical R&D
The Associate Director of Regulatory Affairs will support leads and at times act as the the GRL 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. This is a great role for someone who can thrive in a fast-paced environment and is up for a new challenge for a growing biotech!
- Responsible for coordinating regulatory Submissions and implementing Regulatory Strategy when needed
- 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
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Participate and contribute in Health Authority meetings.
- Working with little to no supervision; self starter
- BS degree required; Life/Health Sciences preferred.
- At least 4-7 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