Title: Associate Director, Global Regulatory Affairs
Company Summary
After the announcement of positive Phase 3 data, this Rare Disease Neurology biotech is looking to strengthen the Regulatory group. It is all hands-on deck to finalize yet another NDA and add to the collection of commercialized products these guys have already placed on the shelves. In addition, with multiple Pre-IND studies, this organization will have additional IND/CTAs to file and initiate first-in-human trials by the end of the year. It is business as usual and they are looking for a Regulatory leader to make it all happen!
Overview
We are looking for a detail oriented and personable Global Regulatory Affairs Associate Director who has experience interacting as the point of contact for both the FDA and other ex-US agencies. This individual should be skilled in and knowledgeable of domestic/global regulations and familiar with IND/CTA and NDA requirements. Lastly, as the Regulatory Affairs Associate Director, you can look forward to mentoring junior members of the team and eventually taking them under your belt to report to you directly.
Responsibilities
- Work with development teams to build strategy and support assigned regulatory submissions
- Represent Regulatory Affairs in multi-disciplinary teams
- Contribute to the implementation of processes and procedures
- Lead and manage submissions to Regulatory authorities on a domestic and global scale
- Act as the point of contact for FDA and other international health authorities
- Effectively coordinate with cross-functional teams to ensure projects are complete in alignment with deadlines
- Provide technical review to ensure accuracy of content
- May supervise employee(s)
- Work hands-on in a dynamic fast-paced environment
- Additional responsibilities as assigned
Experience and Qualifications
- Minimum of 6-8+ years directly related to professional pharmaceutical experience within the Regulatory Affairs industry
- Experience with Neurology desired but not required
- Extensive experience with FDA and other global regulations
- Experience as the point of contract for health agencies
- Ability to work independently and take direction from a mentor
- Contributions and knowledge of IND/CTA/NDA/MAA requirements
- Excellent verbal and written communication skills
Education
- Minimum of bachelor's degree or above is required
If you are interested in the Associate Director, Global Regulatory Affairs position, do not hesitate to apply!
