Regulatory CMC Manager - Cell & Gene Therapy

Key Duties & 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

Required Education Level & Experience

• 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, review, and submission of CMC post-approval variations
• Strong sense of planning, strategic thinking, and problem-solving skills
• Able to collaborate and communicate in an open, clear, complete, timely, and consistent manner
• Able to resolve complex and ambiguous situations with strategic thinking
• 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, including Cell & Gene Therapy Regulatory CMC experience

Contract Length

12 months with the chance to extend

Pay Range

$70/hr - $80/hr

Shift/Hours

Monday–Friday; Remote: EST hours