Regulatory Affairs, Associate Principal - Site CMC- Biologics
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
Job Title: Regulatory Affairs, Associate Principal - Site CMC
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 Biologics Facility.
- Review technical documentation (Project Plans, Change Control, Deviations, CAPA, Batch Records)
- Recommends/approves changes as appropriate to ensure regulatory compliance and conformances with existing regulatory approvals.
- - Provide support for site regulatory inspections
- 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.
- 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 role, or
- Master's degree with 3 years experience in a Regulatory Affairs role, or
- PhD with 2 years experience in a Regulatory Affairs 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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