Regulatory Affairs Manager - Biocides ??? Berkshire

27 Aug 2020
24 Sep 2020
Contract Type
Full Time
Title: Regulatory Affairs Manager

Territory: Berkshire based office

Therapy Area: Biocides

Salary: Highly competitive salary + exceptional benefits on offer

Direct Reports: 1/2

Evolve Consultant: Andy Boyd

Ref: 7498

Looking for the next step in your career?

Join a global, market-leading Healthcare organisation with operations in over 60 countries. Seeking a dynamic and self-motivated Regulatory Affairs Manager with the desire to develop a long-term career within a progressive business.

Role Responsibilities

Management of Regulatory operations:

Management of all registration projects, in relation to Healthcare products, which are relevant to the UK Business

Oversees regulatory strategy and preparation of regulatory documents targeted at the UK market.

Oversees the submission of PSUR, Renewal, Safety variations, and/or variations to the label/leaflets as required in the UK.

Interprets and applies all relevant legislation and regulatory guidelines in the UK and keeps local operating company up to date on national regulatory trends, risks and opportunities for the business.

Oversees regulatory approval procedure for promotional material.

Close collaboration with other regulatory, medical and quality functional groups to ensure the UK business operates in line with strategy and that global strategy takes into account UK peculiar requirements.

External Affairs:

Interface with relevant government agencies (e.g. MHRA), industry associations (PAGB and ABPI) and key opinion leaders to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.

Interface and represent company interests with relevant government agencies, industry associations and/or other organizations.

Audits / Continuous Improvement:

Lead internal investigations into allegations of non-compliance of UK products and coordinate with the qualified personnel the activities necessary to expeditiously resolve local regulatory dispute; assisting in the organization of internal audits and monitor audits performed by 3rd parties.

Assist the Regulatory Affairs Director in conducting internal audits to ensure regulatory and safety compliance.

Role Specific Competencies

Regulatory and product safety experience within an FMCG company

Biocides experience is essential

Thorough understanding of the current regulations, laws and industry requirements

Exceptional ability to manage workload and identify priority tasks to meet tight deadlines

Strong influencing / communication expertise

Ability to build good relationships and challenge constructively and confidently

Ability to consolidate large volumes of complex information, interpret & construct straightforward plans. Naturally inquisitive and interested in brands

Confident and capable of operating at all levels and able to resolve conflict situations

2/3 stage recruitment process:

If you want to hear more about this role, please send us your CV by clicking 'apply now