One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Regulatory Affairs, Principal Associate - Site CMC role
The ideal candidate will have the mix of personal and professional characteristics with emphasis on the following job responsibilities:
· Provide regulatory support for manufacturing operations at the Allston Landing/Framingham Biologics Facility.
· Contribute to the development and implementation of short and long term regulatory strategies for assigned projects and programs.
· Ability to represent the department on project teams.
· Coordinate and prepare document packages for regulatory submissions relevant to assigned projects and programs by ensuring compliance with required regulations and interpretations.
· Review technical documentation and recommend changes as appropriate to ensure regulatory compliance and conformances with existing regulatory approvals.
· Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes.
- Bachelor's degree with 5 years experience in a Regulatory Affairs related role, or
- Master's degree with 3 years experience in a Regulatory Affairs related role, or
- PhD with 2 years experience in a Regulatory Affairs related role.
- Minimum of 5 years' experience working in the biotech, pharmaceutical or medical device industry
- BS, MS or PhD in Biology, Chemistry, Engineering or related field.
- Excellent written and verbal communication skills.
- Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to biologic regulations.
- Strong understanding of biopharmaceutical manufacturing processes
- Excellent organizational skills, demonstrated ability to prioritize multiple projects.
- Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels.
- Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS) for biologics
- Ability to effectively interpret guidance and provide recommendation to key stakeholders.
- RAC certification is a plus.
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