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Regulatory Affairs Manager

Vacancy Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Preston, Lancashire
Industry:
Salary: Negotiable
REF: J897260_1539176306
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Vacancy Published: 6 days ago

Vacancy 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)

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