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Head of Regulatory Affairs

Pharmaceutical

Lancashire £45k – £55k
permanent Job Ref: 6742

Description

A manufacturer of nutritional health products for the veterinary industry is looking for a Head of Regulatory Affairs who will specialise in licensed product regulations to ensure that all products comply with UK and international regulatory guidelines. You will be responsible for leading and managing the regulatory status for all products within the company and will work closely with the Director of Quality & Regulatory Affairs, Head of Research and Development and Company Directors. To apply for this role, you must have a degree in a scientific discipline and have significant experience in Regulatory Affairs and experience Veterinary Medicine and Animal Feed Regulations.

Responsibilities:

  • Lead, manage and motivate of the Regulatory Department team to ensure high standards are maintained at all times.
  • supply monthly project updates to the Company Chairman and Directors.
  • provide support to our International Distributors.
  • give regular updates to the Divisional Directors’ and Company Chairman on regulatory changes and developments in the UK and overseas markets that may or do impact the company.
  • set-up and complete required variations on licensed products to the VMD
  • assist in the pharmacovigilance requirements of the company

Regulatory

  • agree regulatory standards and ensure that there are clearly defined procedures for staff to follow and that these are understood and implemented.
  • work closely with the Quality Department to ensure that all changes are made in line with current regulatory requirements.
  • manage and maintain a system to track all relevant stages relating to registration and licensing.
  • oversee and manage the Product Safety Data Sheets (SDS) to ensure that these are up to date and in line with current regulations.
  • Manage the review and approval of new raw materials.

Dossiers

  • to oversee and manage the production of international regulatory dossiers for registration and or export of products.
  • continuously update all existing dossiers and regulatory compliance documents to ensure that wherever possible all product registrations are current and compliant in every country we sell our products.
  • whenever necessary liaise with the companies QP’s when compiling dossiers for Licence Application.
  • provide the required documentation for international orders, Certificates of Analysis, Health Certificates, and Certificates of Free Sale.

Variations

  • to manage, prepare and progress variations to the company’s manufacturing authorisations to ensure they are maintained - ManA & ManSA
  • to collate, prepare and progress UK product renewals and variations for existing Marketing Authorisations.

Labels/Literature and Packaging

  • 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.
  • sign off on all new and updated labels.

Attributes:

  • bachelor of Science degree (Pharmacy/Chemistry or related discipline) essential
  • minimum five years’ experience in Regulatory Affairs, ideally  in Veterinary Medicine and Animal Feed Regulations
  • experience of working with regulatory bodies such as VMD or MHRA
  • a good understanding of product registration in international markets
  • relevant experience working within a GMP compliant company preferably in a Quality role preferred Good interpersonal skills
  • excellent time management skills
  • good IT Skills
  • proven project planning skills
  • strong written and verbal communication skills
  • highly developed interpersonal and team skills 
  • experience of dealing with external customers
  • ability to work under pressure to meet deadlines
  • strategic thinking individual with the ability to work under own initiative to meet deadlines.
  • able to adapt to change and new circumstances
  • able to work under pressure handling the multiple and complex tasks involved in detailed regulatory work
  • capable of understanding the needs and priorities of the business and translating these into appropriate regulatory actions

good quality IT skills to include Microsoft Word, Excel, PowerPoint and Outlook.


Salary £45k - £55k

Job Ref: 6742