| Job Description | Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. 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. Visit www.genzyme.com.
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.
Qualifications
Basic Qualification:
- 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
Preferred Skills:
- 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. |
| | Company | | Genzyme | Job Code | | State or Province | | Massachusetts | | |
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