Seltek: Senior Manager - Regulatory Affairs | South West | Biotechnology (9398)

International biotechnology business with a worldwide reputation for excellence is looking for a Senior Regulatory Affairs Manager.  The company has a market leading portfolio of industrial bioscience solutions and is able to offer exciting career development opportunities.

The role is based in the South West region and you will be responsible for :

evaluating implications of product and process changes, and advising on regulatory implications of options and regulatory paths for product clearance. Preparing and or overseeing compilation of dossier submissions

leading a UK-based team of 4, managing global regulatory clearance and/or compliance for product lines, in conjunction with regional business regulatory managers

exercising judgment within broadly defined practices and policies in determining regulatory strategies for your areas of responsibility

defining approaches and procedures on new assignments and providing guidance to other personnel

continuously assessing the regulatory landscape and changes in the sector, and what is needed for the company in relation to this; implementation of any needed changes

influencing regulatory/product stewardship policy both internally and externally

translating goals of the company into a strategic plan for your areas of regulatory responsibility

To be qualified for this role you will need a life science degree or Masters with significant experience in regulatory affairs or related areas. Management experience is also required for the role. Any experience in relation to animal nutritional products or raw materials would be an advantage.

To discuss the role in more detail please call Jonathan Pearse on 01279 657716 or email jon@seltekconsultants.co.uk

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