Regulatory CMC (Chemistry, Manufacturing, Controls) Manager

Regulatory CMC (Chemistry, Manufacturing, Controls) Manager

Job description

Job Description

General Summary :

The Regulatory Chemistry Manufacturing Controls (CMC) Manager will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.

This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics.

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 investigational and commercial programs.

Key Duties and 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 investigational and / or 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

Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

Knowledge and Skills :

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.

Education :

Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.

▶️ Regulatory CMC (Chemistry, Manufacturing, Controls) Manager
🖊️ Vertex
📍 Paddington