Remote - Director of Regulatory CMC
The Director of Regulatory CMC is responsible for leading the development and implementation of regulatory strategies for the chemical, manufacturing, and control (CMC) aspects of drug and biologics development programs. The Director will be responsible for interacting with regulatory agencies and internal teams to ensure timely and successful regulatory approvals for new and existing products.
This client is a growing international full-service CDMO within the biotechnology space looking to aggressively expand its footprint in the US. The company has a strong base of Biologics, Clinical Research, Bioanalytical Sciences, DMPK, Cell and Gene Therapy and other capability centers across the US. This business has developed a fantastic brand globally and in the US through exceptional service which drives repeat business.
-Lead the development and implementation of regulatory strategies for CMC aspects of drug development and biologics programs
-Interact with regulatory agencies to ensure timely and successful regulatory approvals for new and existing products
-Develop and maintain regulatory documents, including Investigational New Drug (IND) and New Drug Application (NDA) submissions
-Lead CMC teams and ensure compliance with regulatory guidelines and good manufacturing practices
-Stay up-to-date with current regulatory guidelines and industry trends -Provide guidance and training to internal teams on regulatory requirements
- Bachelors degree in a Scientific Field
- Minimum of 10 years of experience in regulatory affairs, with a focus on CMC
- Strong understanding of FDA and international regulatory requirements for CMC
- Demonstrated knowledge of eCTD elements, structure, and content; expertise in Module 3 and Module 2
- Knowledge in ICH, FDA, EMA and Health Canada guidelines and requirements
- Support cGMP activities as they relate to regulatory affairs submissions: PAI, change control, regulatory assessments, etc.
- Competitive base salary
- Strong commission structure with significant upside
- Get away from bench work and be apart of strategic and business unit
- Ownership of territory
- Excellent benefits package
- Pivotal role for company's aggressive expansion
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.