Title:Associate Director/Director, Regulatory Affairs CMC
We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our growing team. Alternatively, we will also consider applicants with less experience for a Senior Manager position.
The Associate Director/Director of CMC Regulatory will work closely with the CMC team to plan and author high quality global regulatory submissions for the companies small molecule oral drug candidates. This role manages regulatory submissions that meet aggressive timelines, with content that is consistent across development programs, and established on a sound, scientific basis. The Associate Director/Director will develop CMC regulatory submission strategies to manage a product through its life cycle.
This role is remote.
- Work cross functionally to help author, plan and produce high quality regulatory CMC submissions while meeting aggressive timelines
- Ensure regulatory submissions are in line with all relevant CMC guidelines (including FDA, EMA and ICH guidance documents)
- Ensure consistency is maintained in regulatory submissions across development and commercial projects, and that sound scientific justification is employed in CMC regulatory strategy
- Apply up to date knowledge of regulatory requirements, and communicate changes in regulatory information to project teams and management
- Represent regulatory CMC in project teams
- Liaise with Imago's external publisher and review published regulatory CMC documents prior to submission
- Work closely with VP, Regulatory to help shape the recently created regulatory department and establish effective working procedures
- A minimum of 5-10 years pharmaceutical/biotech industry experience including a minimum of 5 years of relevant regulatory CMC experience, with the majority being for small molecules
- BS, MS, or PhD in Chemistry or related field
- Phase 3/NDA experience for small molecule solid oral dosage forms preferred
- Knowledge of regulatory CMC requirements, including ICH and FDA/EMA requirements
- Excellent verbal and written communication skills, and interpersonal skills
- Experience in authoring independently without supervision a variety of CMC components of regulatory submissions, and responses to agency questions
- Experience with CMC requirements for drug development of new small molecule entities
- Ability to develop and implement regulatory submission strategies
- Ability to collaborate with cross functional teams in the preparation of complex submissions.
- In-depth knowledge of Module 3 CTD structure
If you are interested in the AD/Director, Regulatory Affairs CMC role, please dont hesitate to apply!