Regulatory Affairs Manager - Pharmaceutical
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.
- 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
- 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)