• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

General Position Summary

The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation. This role also 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.

Key Duties & Responsibilities

• 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

Required Education Level & Experience

• 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