Connecting...

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Blackpool, Lancashire
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: J894286_1518179499
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: February 09, 2018 12:31

Job Description

Regulatory Affairs Manager - Veterinary/Pharmaceutical/Biocide

Location: Blackpool, Preston, Southport, Lancaster, Blackburn

Type: Permanent (and temporary positions available)

Salary: Highly competitive - includes bonus and healthcare

Hours: Days (flexitime)

Our Client are a leading - multi sited Nutritional Manufacturer who are going through significant growth, which has led to two opportunities and a significant investment into the regulatory functions.

Reporting to the Head of Regulatory Affairs, the Regulatory Affairs Manager will support the group companies in the registration of a range of licensed veterinary products, animal nutritional supplements and equine products for the UK and international markets.

This will include:

  • To provide regulatory knowledge on ingredient and product changes and maintenance issues.
  • To Co-ordinate regulatory documentation to support product changes and registration in both the UK and international markets.
  • To provide appropriate summaries and options resulting from changes to regulations.
  • To provide training to staff in regard to regulatory changes and for mandatory revisions.
  • Lead the organisations Pharmacovigilance requirements.

Licenced Products

  • Prepare and progress variations to the company's manufacturing authorisations to ensure they are maintained (ManA & ManSA).
  • Collate, prepare and progress veterinary Medicine renewals and variations for existing Marketing Authorisations.
  • Work closely with the Quality department to ensure that any changes are made in line with regulatory requirements.

Feed / Nutraceutical Products

  • Ensure that all product labels, literature and packaging complies with the appropriate legislation (e.g. Equine Prohibited Substances, Feeding Stuffs Regulations, Veterinary Medicines Regulations guidelines) in both UK and international markets.
  • Perform regulatory checks on new and updated labels.
  • Maintain a system to track all relevant stages of registration and licensing.

Export Markets

  • Perform continuous analysis on existing dossiers and update regulatory compliance documents to ensure all product registrations are current and compliant in each country.
  • Produce regulatory dossiers for registration and export of products to international markets.
  • Provide continuous support to the International Distributors.
  • Present required documentation for international orders (i.e. Certificates of Analysis, Health Certificates, and Certificates of Free Sale.
  • Maintain a system to track all relevant stages of registration and licensing.

Miscellaneous

  • Ensure Safety Data Sheets (MSDS) are up to date and in line with current regulations for all products within the Client Group.
  • Train staff regarding regulatory changes and for mandatory revisions.

The Person:

  • Will hold a Degree in a relevant Scientific discipline
  • Will have significant RA experience (ideally in nutritional, supplement or veterinary industries) - we are looking for 5 years plus experience ideally here.
  • Knowledge of biocides (preferable) ((BPR)).
  • 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.
  • Good interpersonal skills.
  • Excellent time management skills.