• Contributes to development of programs/processes that support development of Investigational or New Drug Applications.
• Collaborates with other departments to execute CMC submission activities, including meeting requests and briefing documents, for INDs/NDAs submitted to regulatory agencies.
• Executes the timely preparation and submission of high quality CMC content for submissions of all types and their amendments and supplements.
• Lends functional expertise and supports all CMC related discussions, negotiations and responses with FDA.
• Interfaces with technical, regulatory or clinical colleagues in overseas, as required, on CMC related projects and issues.
• 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.
Minimum B.S. in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering or related
field. Advanced degree (M.S. or Ph.D.) preferred.
Minimum 5-8 years of experience in Regulatory Affairs which included preparing CMC submissions to regulatory agencies and direct interaction with regulatory authorities
CMC module writing experience and some global/international experience is preferred
Knowledge and Skills:
Knowledge of FDA and ICH regulations/guidance as it applies to CMC/Quality
Working knowledge of DP and API GMP is preferred
Strong project management abilities
Experience working in a multi-cultural, multi-lingual environment
Demonstrated ability to contribute successfully in a multi-disciplinary team environment /matrix organization
Competency in MS Office, MS Project and Lotus Notes