Regulatory CMC Manager
Listed on 2026-10-05
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Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance, Medical Science Liaison
The Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation, including clinical trial submissions, and provides regulatory support to various cross-functional teams with a focus on Biologics.
Key Duties and Responsibilities- Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada, and ICH) guidelines
- Strong problem-solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Sound knowledge of cGMP, FDA, EMA, ICH
$75-$80/HR
Requisition DisclaimerThis job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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