Relaytherapeutics
Associate Director/Director, CMC Regulatory
Cambridge, MA. Posted 2 months ago
The role
This person will lead the execution of regulatory CMC investigational, registration, and post-approval strategies for development programs. They will develop global submission plans and coordinate responses to regulatory authority questions.
What you will do
- Develop and execute CMC global submission plans and timelines
- Lead the execution of regulatory CMC investigational, registration and/or post-approval strategies
- Apply global regulatory CMC knowledge to address challenges during development and commercialization
- Lead and coordinate responses to CMC questions/RFIs from regulatory authorities
- Define CMC content requirements for regulatory submissions and review for conformance
- Act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management
- Manage CMC-regulatory assessment and guidance on product compliance topics
- Communicate CMC regulatory strategies, key issues and risks to cross-functional teams
- Keep abreast of regulatory guidance and technical/scientific developments
Required qualifications
- Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields
- Minimum of 8-10+ years of relevant experience in regulatory-CMC and/or within CMC function in the biotech/pharmaceutical industry
- Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance
- Knowledge of eCTD Modules and QOS requirements for INDs/IMPDs and NDAs/MAAs
- Experience managing submissions in RIM Veeva or equivalent
- Document formatting/Quality Control compliant with eCTD templates / requirements
Nice to have
- focus on small molecule (preferably solid orals: tablets, capsules)
- focus preferably on CMC for small molecules and oral solid products
About the company
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. They use a Dynamo platform to integrate experimental and computational approaches to drug protein targets.