Regulatory Affairs Consultant

High Wycombe
09 Jan 2019
06 Feb 2019
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and are looking to recruit a Senior Regulatory Consultant on an initial 6 Month contract basis to be based at there offices in Buckinghamshire.

The role will be involved with day to day Regulatory Activities related to providing strategic input within Development, Post Approval and Life Cycle Management.

Key Responsibilities/Requirements:

* Preparing and submission of Regulatory documents.

* Working to deadlines for multiple projects, focussing on labelling and strategic planning.

* Implementation of Risk Management Plans also coordinating cross functional teams to implement educational material.

* Liaising with Regulatory Authorities including RFI’s.

* Manages submissions of MAA’s, defines processes, submission plans and advise team on submissions strategies.

Skills/Experience Required:

* Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology

* Ideal candidate would possess an extensive experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Pips, Regulatory Affairs, and associated legal requirements is also required.

* Strong working knowledge within multiple portfolios

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

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