Job Ref: 212821094

Date: 2020-11-27 11:08:10

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Director Regulatory Affairs CMC –

Buckinghamshire (Remote working available)

Salary – Competitive with benefit package

Vantage Consulting are partnered with a global consultancy specialising in providing services across the biotechnology and pharmaceutical sectors in their search for a Director of Regulatory Affairs CMC. This role has come about due to a period of sustained growth in this area and a demand for more support to their growing client base. The successful candidate will be an experienced Regulatory Affairs specialist with particular strengths in CMC biologics. As Director Regulatory Affairs CMC, the successful candidate will be expected to be able to defend the company position in front of the FDA and other such bodies.

Due to the fact that this is a consultancy business, the successful candidate will not only bring experience in overseeing the authoring and amendment of regulatory dossiers, there will be an expectation that you will be willing to roll up your sleeves and provide help and guidance to authors with recent experience of authoring Module 3 documents themselves.

You will be Degree educated in natural science with a preference for Medicine, Pharmacy, Chemistry or Biology (ideally with PhD)

You will need thorough knowledge in the field of Regulatory CMC accompanied by several years experience identifying needs in CMC and related areas. From either a service provider or cross departmental company perspective.

Due to the variety of clients you will be working with, you'll need knowledge of and experience in regulatory processes, responsibilities and needs in multinational pharmaceutical companies.

Day to day responsibilities –

Develop new CMC large volume services approaches through market, competitor and client need analysis
Define global REG CMC approaches to support large volume and complex programs.
Author CMC proposals focusing around complex program proposals in collaboration with the Heads of Regulatory Service Areas – Business Development, Program Management and Regional Management.
Represent CMC in complex and strategic bid defence meetings and client interactions – i.e. FDA
Deputise for Head of Global Regulatory CMC
Support the Head of Global Regulatory CMC and other REG Service Areas in defining regulations and processes within CMC.
Ability to professionally represent the company both externally and internally

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