Regulatory CMC Manager - Small Molecule (Contract)

Vertex Pharmaceuticals • Remote,

9d • $70 - $80 • Remote

About The Position

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.

Requirements

• 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
• 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

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

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager