CMC Regulatory Affairs Manager
Position Summary: An individual in this role is expected to coordinate all aspects of CMC regulatory submissions relevant to their assigned projects. An individual in this role will serve as the regulatory CMC representative on matrix teams, as appropriate.
- Monitor changes to development plans and work with supervisor to design globally compliant CMC regulatory strategy for development products with supervision.
- Drive global CMC regulatory submission activities (IND, CTA, NDA, BLA) with supervisor.
- Support in the coordination and preparation for health authority interactions (meeting requests and briefing documents)
- Assess CMC regulatory requirements for assigned projects in collaboration with supervisor to ensure all development activities are in compliance with applicable regulations and guidelines
- Interface with Millennium Quality systems in compliance with Corporate SOPs.
- Review analytical procedures, specifications documents, comparability protocols, validation protocols, and stability protocols for consistency with relevant global regulations and guidelines under the direction of a supervisor.
- Ensure the quality and content of all submissions to health authorities.
Working hours: 8:30-5:30
Experience: A minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field. Must have a minimum of 2-4 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.
Other: Understanding of the drug development process and knowledge of FDA, EU, Canada, and ROW regulatory requirements. Project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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- May 6, 2013 MassBio Recognizes Marlborough as a Major Life Sciences Hub in Massachusetts: PR.com - 5/5/2013
- May 6, 2013 Elections may have big impact on tech, biotech: Boston Globe - 5/5/2013