Regulatory CMC Manager (Contract)

Vertex Pharmaceuticals • US - Remote,

1d • $70 - $80 • Remote

About The Position

The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable international regulatory requirements are considered and appropriately incorporated into the lifecycle of cell and gene therapy programs.

Requirements

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in FDA, EMA and international regulatory guidelines
• Experience in the preparation, reviews and submissions of CMC post approval variations
• Strong sense of planning, strategic thinking and problem-solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Capable of strategic thinking with ability to resolve complex and ambiguous situations
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• 5 years of Regulatory CMC experience, preferably in the biologics or cell and gene therapy field

Responsibilities

• 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
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• 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: Mid Level