Title: Associate Director, Regulatory Affairs
Company Summary
One of the most up-and-coming rare liver disease biotech's in the Bay Area is looking to make a crucial Regulatory hire to their team. They seek a professional with the appetite to roll up their sleeves and make a strong impact on both the department and company as a whole. The team is passionate about the work that they do, making the company culture something to get excited about. The staff are incredibly talented, collaborative, and strive to develop the most innovative and ground-breaking treatments the industry has yet to discover. With significant developments over the course of the last two years, these guys have brought more than 3 indications to the clinic and continue to shock the industry with innovative treatments for rare liver diseases. With the backing of a brilliant staff and promising drug candidates, this opportunity will not only impact your career beyond anything you could have imagined but, also has the potential to become the most lucrative decision you've ever made.
Overview
We are looking for a detail oriented and personable Regulatory Affairs Associate Director who has a working knowledge of both U.S. and global regulations. This position will require collaboration with cross-functional professionals and execution of regulatory strategy for all submissions. You will be responsible to contribute to the writing and development of regulatory submissions and represent the organization directly to health authorities.
Responsibilities
- Develop and execute clinical and non-clinical regulatory strategies
- Represents Regulatory Affairs at team meetings
- Provide strategic leadership for regulatory submissions which include IND/CTA, NDA/MAA
- Responsible for interactions with FDA and other global health authorities
- Complies and coordinates regulatory documents for submission
- Develop essential timelines for all tasks
- Work cross-functionally with clinical, project management, quality, etc. teams
- Participate as a core member of the Regulatory Affairs team
- Work hands-on in a dynamic fast-paced environment
Experience and Qualifications
- Minimum of 8+ years direct related professional experience with a minimum of 6+ years within Regulatory Affairs
- Experience with rare disease and small molecules is strongly desired
- Extensive experience compiling regulatory documents such as IND/CTA, NDA/MAA
- Proven track record and experience with review of regulatory strategies in alignment with regulations and guidelines
- Significant knowledge and understanding of guidelines
- Ability to work independently and take direction from a mentor
- Interpret Regulatory Affairs documents, submissions, and reports
- Excellent verbal and written communication skills
Education
- Minimum of bachelor's degree or above in a life sciences field from an accredited college or university required.
- An advanced degree preferred
If you are interested in the Associate Director of Regulatory Affairs role, do not hesitate to apply!
