Science Regulatory Specialist Jobs
Laboratory, Bench Scientist, Scientific, Life Scientist , Research And Development,

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Covering the following locations: Cardiff

Currently recruiting for an exciting opportunity for an experienced Regulatory Specialist to provide specialist support in regulatory affairs.
In this customer-centric role, you will be the primary person who will provide support for regulatory matters to ensure compliance with current and future global enzyme regulations within our different sectors. You will lead and coordinate our regulatory approval submissions for new enzymes; and will have a strong understanding of global food/pharma legislation.

Key Activities:
Ensure compliance of products with EU regulation No 1332/2008
Ensure compliance products with other geographical regulations as required
Provides regulatory advice, support and timely responses to customer regulatory enquiries (country permissibility) as specified in Service Level Agreements
Work with project team to ensure regulatory requirements are achieved for new product development
Be responsible for or support compilation and submission of dossiers for regulatory approval for new products
Effective planning and monitoring of regulatory approvals
Proactively develops strong collaborative working relationships with external stakeholders including consultants, trade organisations and regulatory bodies.
Responsibility of creating and maintaining document control systems for regulatory and quality documentation for raw materials and products.
Support New Product Development and Marketing teams by providing regulatory guidance to ensure compliance through all stages of new product development and entry into new markets
Keeps up to date and the company informed of all relevant legislation, regulatory guidelines, regulatory trends, opportunities, interprets regulatory issues and risks
Carry out the responsibilities stated in the Managing Director's Health & Safety Policy detailed in paragraphs 9 and 10 of his management Directive
Be conversant with and adopt the procedures stated in the Environmental Management System (EMS) Manual and its supporting documents

Person Specification
A degree in science, regulatory affairs or equivalent is desirable; but more importantly, demonstrable experience working in a regulatory affairs or quality assurance environment is essential.
You must possess excellent administrative skills; be able to work independently and proactively, planning and organising your work systematically and methodically. You will need to demonstrate a natural ability to communicate in a positive and friendly way; including with our partners and customers outside of the UK. While also being able to multi-task and deliver high quality work on time and to a first-rate standard.
Please note, that post-COVID, the successful candidate will ideally be able to, on occasion, travel to our European-based sites (approx. 2-4 times per year for no more than a week at a time).

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* Salary Guide
Home Based
Job Ref: 66325

Nick Walker

Scientific Recruiter 01494 818 059

James Higgins

Scientific Resourcer 01494 818 009

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