Job Reference: J5631504
Updated On: 15/05/2019
Status: Open to Applications
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Senior Regulatory Affairs Consultant
Role OverviewAn exciting opportunity for a Senior Regulatory Affairs Consultant has become available to join a leading Consultancy based in the Cambridgeshire area. As the Senior Regulatory Affairs Consultant you will be responsible for advising both internal and external clients on the Regulations surrounding Pharmaceutical Drug Development including Non-Clinical, Pre-Clinical and CMC Regulatory activities.
You will be instrumental in the development of Regulatory Strategy for early stage product development and you will have the opportunity to use the technical knowledge you have developed through your career to offer a unique regulatory perspective to world leading Pharmaceutical companies.
Key Duties and ResponsibilitiesYour duties as the Senior Regulatory Affairs Consultant will be varied however the key duties and responsibilities are as follows:
1. Provide expert Regulatory guidance to internal and external clients with a focus on Pharmaceutical product development (Non-Clinical, Pre-Clinical and CMC). You will achieve this through client meetings both Face to face and teleconference.
2. Prepare, review, submit and project manage regulatory submissions in compliance with the applicable company SOPs, regulatory guidelines and legislation.
3. Participate in business development activities to ensure the success of the Regulatory consultancy.
4. Attend internal and external training courses, meetings and conferences to maintain up to date Regulatory knowledge.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Consultant we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (E.g. Biology, Chemistry, Pharmacology, Drug Discovery etc.), ideally with hands on experience in a Technically focused position.
2. Proven industry experience in a Regulatory Affairs focus position, ideally with experience of pre-clinical and/or clinical regulatory activities in EU and US markets.
3. A working knowledge and practical experience with Regulatory project management from early stage to post-marketing submissions
Key Words: Regulatory Affairs | Pre - Clinical | Non - Clinical | Clinical | CMC | Drug Development | Early Stage Development | EU | EMA | MHRA | US | FDA | Regulatory Strategy | PIP | PRIME | Scientific Advice
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