Associate Director, Regulatory Affairs
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.
Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com
Associate Director Regulatory Affairs, CMC Biologics
Reporting to the Senior Director, Regulatory Affairs, this position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical products; both small molecule and biological proteins. This position will provide product strategy and direction to commercial and clinical teams. Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Incumbent will lead a team of regulatory professionals and be responsible for their development. Experience working in a matrix environment and excellent people skills are required.
Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
Provide support for other CMC projects as needed.
- M.S. degree in a scientific discipline with 6 years regulatory experience, or B.S. with 8 years regulatory experience; .
- Knowledge of FDA regulatory submission requirements is essential.
- 4-6 years Biologics experience required.
- Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
- Excellent organizational and communication (written and verbal) skills.
- Demonstrated ability to work successfully on project teams.
- RAC certification preferred.
- Previous experience working in a fast paced environment on multiple product lines
- PhD is considered a plus
- Manufacturing, QA/QC experience
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