CMC (Regulatory) Consultant
The CMC (Chemistry, Manufacturing and Controls) Consultant will support the implementation of Company local and global Company strategies. He/she will provide support for cross-functional collaborations to integrate CMC programs for Company investigational products. The incumbent is also responsible for leading aspects of CMC regulatory submissions and will serve as an internal representative/contact for CMC regulatory activities.
- Must be able to work on-site full-time.
- Contributes to development of programs/processes that support development of Investigational or New Drug Applications.
- Collaborates with CMC counterparts overseas and other departments to execute CMC submission activities, including meeting requests and briefing documents for FDA meetings, and INDs/NDAs submitted to regulatory agencies.
- Executes the timely preparation, review and submission of high-quality CMC content for Company submissions of all types and their amendments and supplements as assigned.
- Lends functional expertise and supports CMC related discussions, negotiations and responses with FDA and internal stakeholders such as Production Technology, Quality Operations, Commercial manufacturing, Supply chain, etc.
- Interfaces with technical, and regulatory in Japan, as required, on CMC related projects and issues.
- Support global CMC process development and improvement as required.
- Provides ongoing lifecycle support for marketed commercial products.
- Evaluates and contributes to the outsourcing of manufacturing efforts and change controls, the assessment of regulatory impacts, and provides support for their implementation.
- Represents Regulatory Affairs CMC function, as required, at various cross-functional team meetings and working group meetings, providing solutions when possible to the project teams on CMC related problems. Escalates more complex issues to the Sr. Director, CMC.
- Maintains up-to-date knowledge of relevant FDA and ICH requirements relating to CMC activities.
- Advises and updates teams on the impact of new legislation, regulations and guidance on development plans and registration strategy as it relates to CMC sections for INDs/NDAs.
- Education: Minimum B.S. in Pharmacy, Chemistry, Chemical Engineering or related field
- Advanced degree (M.S. or Ph.D.) is preferred
Experience & Skills Required
- No remote workers.
- Professional Experience: Minimum 5-8 years of experience in CMC activities including submissions to regulatory agencies, interaction with regulatory authorities, and CMC module development and review experience
- Knowledge and Skills: Strong knowledge of pharmaceutical development of drug substance and drug product
- Knowledge of FDA and ICH regulations/guidance as it applies to CMC/Quality
- Project management abilities
- Experience working in a multi-cultural, multi-lingual environment; Japanese company experience is preferred but not required
- Demonstrated ability to contribute successfully in a multi-disciplinary team environment/matrix organization
- Working knowledge of DP and API GMP is preferred
- Competency in MS Office, MS Project
- Willingness to travel domestically up to 10%