We are seeking an experienced Senior Director of Global Regulatory CMC within the pharmaceutical industry. Our client is a leading pharmaceutical company with a strong pipeline of products who stay committed to developing innovative therapies that improve the lives of patients. The role is based in Boston, MA, and the successful candidate will be responsible for managing regulatory strategies in small molecules in early development.
Responsibilities:
The main responsibilities of the Sr Director GRA CMC Small Molecule role include:
- Leading the global regulatory CMC Early Development team
- Managing regulatory strategies for small molecules at the early development phase
- Providing leadership and guidance to ensure regulatory compliance
- Developing and implementing global regulatory strategies
- Ensuring timely regulatory submissions
- Maintaining awareness of relevant regulatory guidelines and requirements
- Providing support to cross-functional teams
Skills:
The ideal candidate for the Sr Director GRA CMC Small Molecule role will have the following skills:
- 15+ years of experience in regulatory affairs
- Strong leadership skills
- Excellent communication skills
- Ability to manage complex projects
- Knowledge of global regulatory requirements
- Experience with small molecule development
