Regulatory CMC Manager - Small Molecule (Contract)

The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.

This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.

Key Duties and Responsibilities

• Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions.
• Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
• 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 in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Knowledge/Skills

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
• Strong problem-solving skills and the ability to present the overall assessment for management alignment
• Ability to collaborate and communicate in an open, clear, complete and timely manner
• Strong sense of planning and prioritization, with demonstrated results

Required Education Level & Experience

• 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 5 years of experience in the pharmaceutical industry or related field
• Experience supporting Small Molecule programs required

Contract length: 12 months with the chance to extend.

$70/hr. - $80/hr.

Monday–Friday; Remote: EST hours

This 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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