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Role Filled

Regulatory Affairs Manager

Animal Health
Technical Specialist
Regulatory Affairs
Preston, Lancashire
£0 - £50K
Companion Animals
Nutraceuticals & Nutrition
Vets - Corporate group
Vets - Independent

Role Overview

Main purpose of the role:
– to support the Head of Regulatory Affairs in the registration of a range of licensed veterinary products, animal nutritional supplements and equine products for the UK and international markets

Location: 5 days a week in Lytham St Anne’s.

Company Information

Leading manufacturer and supplier of nutraceuticals to the veterinary industry.

Role Requirements

Main Duties: 70%

” The Regulatory Affairs Manager must be capable of working with the Head of Regulatory Affairs to implement and manage the regulatory status for all products.

” Based on current knowledge and experience this may include:
Licenced Products
o To prepare and progress variations to the company’s manufacturing authorisations to ensure they are maintained (ManA & ManSA).
o To collate, prepare and progress Veterinary Marketing Authorisations variations, renewals and, if necessary new applications, etc.
o Work closely with the Quality department to ensure that any changes are made in line with regulatory requirements.
” Support the Company’s QPPV and deputy QPPV (dQPPV) for Vetplus Ltd which includes the preparation of PSURs for approval and submission by the QPPV.
” Support the Company’s QPPV and dQPPV for Gibraltar (UK) Ltd on behalf of the product distributor Farmsense, which includes the preparation of PSURs for approval and submission by the QPPV.
o Perform regulatory checks on in-house training material, advertisements and marketing promotional material for licensed medicinal products, to ensure they meet relevant standards and guidelines.

Feed / Nutraceutical Products
o To ensure that all product labels, literature and packaging complies with the appropriate legislation in UK and the appropriate international markets.
o Perform regulatory checks on new and updated labels.
o Maintain a system to track all relevant stages of registration and licensing.
o Perform regulatory checks on in-house training material, advertisements and marketing promotional material for new and existing Feed/Nutraceutical products.

Export Markets
o Perform continuous analysis on existing dossiers and update regulatory compliance documents to ensure all product registrations are current and compliant in each country.
o Produce regulatory dossiers for registration and export of products to international markets.
o Provide continuous support to the International Distributors.
o Provide or support the completion to appropriate standards any required documentation for international orders (e.g. EHC, CN numbers, CofA’s etc)
o Maintain a system to track all relevant stages of registration and licensing.

Miscellaneous
o To ensure any required Safety Data Sheets (SDS) are up to date and in line with current regulations.
o Provide regular updates on regulatory changes and developments in the UK and current markets that impact the company to the Head of Regulatory Affairs
o Provide training to staff regarding regulatory changes and for mandatory revisions.
o Provide training, direction, mentoring and manage less experienced (junior) staff

Occasional Duties: 30%

” Attend staff meetings and training as required.
” Occasional travel to other sites may be required.
” Occasional travel to meet with relevant governing bodies/consultants.
” Deputise for Head of Regulatory Affairs as required.
” Carry out any other duties as are within the scope, spirit and purpose of the job, the title of the post and it’s grading as requested by the line manager.

Person Specifications

Ideal profile required:
· Bachelor of Science degree (Pharmacy/Chemistry or related discipline) essential
· 3+ years’ experience in Regulatory Affairs, ideally in Veterinary Medicine and Animal Feed Regulations
· Knowledge of biocides (preferable)
· Knowledge of NPD and/or formulating products (preferable)
· Experience of working with regulatory bodies such as VMD or MHRA
· Knowledge and understanding of the role and responsibility of a Qualified Person for Pharmacovigilance, as it relates to Veterinary products (preferable)
· Experience of product registration in international markets

Package

Base Salary: d.o.e. plus a competitive benefits package.

Locations

Barrow
Kendal
Lancaster
Morecambe
Previous Listing
Date Updated
18 Jan 2024
Job reference
69994
Categories
Full Time
Permanent
Take Experience
This role has been filled
This role has been filled
Why Zenopa?

We aim to operate and maintain the following set of core values

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01
In house, contracting department.

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02
We liaise on your behalf

Required equipment, e.g. cars, laptops, mobiles, we negotiate with the employer source and manage these on your behalf.

03
Solid Industry Relationships

Our recruitment teams have built relationships with some of the UK’s most prestigious pharmaceutical companies

04
High Success Rate

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05
Systems that work for you

As an ISO 9000 organisation we have fully defined systems that are regularly audited. You can be assured we consistently following processes that deliver for all.