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Head of Regulatory CMC

Surrey, SurreyPermanent
Experience Dependant
Job Reference: J5633249
Updated On: 28/04/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology

Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - Global, Regulatory Affairs - Operations, Regulatory Affairs - CMC, Regulatory Affairs - Manager / Director / Executive, Regulatory Affairs - Biologics

Job Information

Role Overview

We are currently looking for a Head of Regulatory CMC to join a leading Biopharmaceutical company based in the South of England. As the Head of Regulatory CMC you will be responsible for a Global team of Regulatory professionals focused on offering compliant regulatory solutions to support the development and maintenance of speciality Biological products.

You will lead the development of strategy and operational plans for all Regulatory CMC aspects and liaise directly with key stakeholders across Quality, Technical, Manufacturing and Commercial departments. This is a leadership and people management position where you will have multiple teams in international locations.

Key Duties and Responsibilities

Your duties as the Head of Regulatory CMC will be varied however the key duties and responsibilities are as follows:

1. Develop, support and manage an expert team of Regulatory Affairs CMC and Operations staff across EU sites focused on the preparation of high quality, compliant CMC and life cycle maintenance dossiers including clinical trial IMPDs/ INDs, Marketing Authorization Applications, post-approval variations, renewals, PSURs and responses to agency requests for information.

2. Be the primary point between regulatory CMC/Operations and internal stakeholders including Manufacturing Operations, QA and Commercial. You will report directly to the Head of Global Regulatory Affairs and lead the planning and execution of strategy for regulatory CMC, labelling and Operations aspects of development and approval of new drugs as well as commercial product life cycle management activities.

3. Manage regulatory change control activities including the development and maintenance of efficient, robust and compliant systems and processes to assesses the regulatory impact of all change controls; evaluate and communicate priorities and provide clarity on project accountability.

4. Oversee Labelling projects and lifecycle activities as well as leading Regulatory operations. You will also ensure Regulatory compliance of systems across the business.

Role Requirements

To be successful in your application to this exciting opportunity as the Head of Regulatory CMC we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Science discipline in addition to extensive Regulatory Affairs experience with exposure to all areas of Regulatory Affairs, ideally experience of the manufacturing of Biological products, Specials or NPP..

2. Proven industry experience of Regulatory Submissions including the preparation and review of submissions, ideally to a range of markets with exposure to a range of submissions systems.

3. Extensive knowledge of Regulatory CMC for products in development and manufacture with experience of the management of change control processes.


Key Words: Regulatory Affairs | Regulatory CMC | Manufacturing | Pharmaceutical | Biopharmaceutical | Specials | Immunotherapy | Quality| Operations | MAA | EMA | CTA | IND | IMPDs | Change Control | Head of | Director | Lead | Manager | Global | International markets | South East | West Sussex | Surrey
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.