Regulatory Affairs Manager

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.