Regulatory CMC Manager, Cell and Gene Therapy

Role Overview

• Support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products
• Contributes to the preparation and submission of regulatory CMC documentation
• Provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs
• 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 colleagues in development of global regulatory CMC strategies and Submissions
• 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

Requirements

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and 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
• Capable of strategic thinking with ability to resolve complex and ambiguous situations
• Sound knowledge of cGMP, FDA, EMA, ICH
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.