Mark Heintzelman
- Role
- Associate Vice President Reg Cmc Small Molecule Development at Sanofi
- Location
- Kingston, NH, US
- LinkedIn followers
- 500 followers
Experience
Associate Vice President Reg Cmc Small Molecule Development
Oct 2015 — Present
October 2015 – Present: Associate Vice President CMC Regulatory Affairs Small Molecule Development, Sanofi, Westborough, Massachusetts. Oversee see a small molecule development group in Regulatory CMC. Work with my team to assure molecules are developed according to company and international regulatory standards. Assure that products move thru CMC channels and progress along with phased requirements. Interact with molecule partner companies to assure that relationships and ways of working are positive. Conduct and oversee Due Diligence activities as required. Initiate MAA/NDA/JNDA and worldwide license applications for products reaching license application stage. After global approvals have been reached, hand over molecules to commercial side of RegCMC. Work on development projects for approved molecules as CMC changes are required. Interface with Research and Development organization to provide expert advice on projects and serve as a mentor to junior staff. Our job is to get new products licensed. Manage budget, hiring and planning on a yearly basis.
Skills
- Genetics
- Clinical Research
- Biologics
- Quality Control
- Clinical Development
- Regulatory Requirements
- Drug Development
- Biotechnology
- Chemistry
- Regulatory Affairs
- Quality Assurance
- Fda
- Monoclonal Antibodies
- Licensing
- Product Development
- Biopharmaceuticals
- Ind
- Protein Chemistry
- Strategy
- Cmc
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