Regulatory Affair Manager

Blackfield Associates
London (Greater)
10 Feb 2018
15 Feb 2018
Contract Type
Full Time
Regulatory Affairs Manager (CMC) - London - 12 month Contract

Blackfield Associate are currently looking for a Regulatory Affairs Manager within CMC to join a leading company based in the London area. As the Regulatory Affairs Manager you will be responsible for supporting the development programmes in place, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements.

The key area of the role are as follows

Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:

- To liaise closely with relevant departments of the organisation and external collaborators to ensure proposed developments are fit for purpose and suitably planned whilst ensuring the development programme will meet regulatory and quality requirements.
- To help develop an agreed CMC and regulatory strategy and implementation plan for each programme.
Prepare regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc) to meet business needs and agreed time, cost and quality standards.
- Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals.

To be successful in this role you will need to have the following-

- Relevant degree in a Life Science.
- Proven industry experience working in a regulated GMP environment.
- A working knowledge and practical experience of registration of cell and gene therapies for clinical trial throughout the EU, and US an advantage.

This role is based on a 9-12 months contract and will be looking pay £50,000 - £55,000. If you are interested in this role please contact Vik Patel at Blackfield Associates on Phone number removed or email me with your CV and covering letter on Email address removed

STR Limited is acting as an Employment Agency in relation to this vacancy.

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