Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Preston, Lancashire
Salary: Negotiable
Reference: J897260_1539176306
Contact Name: Tom Hammond
Contact Email:
Job Published: October 10, 2018 13:58

Job Description

Regulatory Affairs Manager - Pharmaceutical

Location: Preston

Type: Permanent

Hours: 8:00am - 5:00pm (1 hour for lunch)

Salary: Very competitive basic package (includes pension, private healthcare etc)

Reports to: Head of Regulatory Affairs

Our Client, a large Pharmaceutical/Nutraceutical company based near to Preston; is looking for an experienced Regulatory Manager who will work as a key part of their NEW Regulatory team. This role has been created through growth and expansion; it offers a fantastic remuneration package and the chance to work for a company- very much on the rise.

The Role:

  • To provide regulatory knowledge and insight on ingredient and product changes/ issues.
  • To Co-ordinate the regulatory documentation to support product changes and registration (both the UK and international markets)
  • Providing training to staff in regards to regulatory changes and mandatory revisions.
  • Leading the organisations Pharmacovigilance requirements
  • To prepare and progress variations to the company's manufacturing authorisations to ensure they are maintained
  • Work closely with the Quality department to ensure that any changes are made in line with regulatory requirements.
  • Act as the Company's QPPV for numerous licences and products (e.g. VMD)
  • To ensure that all product labels, literature and packaging complies with the appropriate legislation in UK and, appropriate, international markets.
  • Maintain a system to track all relevant stages of registration and licensing.
  • 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.
  • To ensure any required Safety Data Sheets (SDS) are up to date and in line with current regulations.
  • Provide regular updates on regulatory changes and developments in the UK and current markets that impact the company to the Head of Regulatory Affairs
  • Provide training to staff regarding regulatory changes and for mandatory revisions.
  • Provide training, direction, mentoring and manage less experienced (junior) staff

The Person:

  • Must hold a Degree in a relevant Scientific Discipline
  • 6+ years' experience in Regulatory Affairs, ideally in Veterinary (VMD markets); Pharmaceutical will be considered.
  • 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)

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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