Senior Director Regulatory CMC
We are currently seeking a Senior Director Regulatory CMC to join a leading pharmaceutical company based in Cambridge, United States. As a Senior Director Regulatory CMC, you will be responsible for the development of CMC regulatory strategies for small molecule products in early development.
Responsibilities
- Develop and implement regulatory CMC strategies for small molecule products in early development.
- Provide regulatory CMC guidance to cross-functional teams.
- Ensure compliance with global regulatory requirements and guidelines.
- Develop and maintain relationships with regulatory authorities.
- Manage regulatory CMC activities for assigned projects.
- Work collaboratively with internal and external stakeholders to ensure timely delivery of regulatory CMC milestones.
- Provide regulatory CMC support for due diligence activities.
Skills
- Strong knowledge of global regulatory CMC requirements and guidelines.
- Experience in developing and implementing regulatory CMC strategies for small molecule products in early development.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively with cross-functional teams.
- Strong project management skills.
Requirements
- Bachelor's degree in life sciences or related field.
- 15+ years of experience in regulatory CMC within the pharmaceutical industry.
- Experience with small molecule products in early development.
