Role: Regulatory Affairs Assistant / Executive
Salary: Highly Competitive
Russell Taylor Group has a fantastic opportunity for a Regulatory Affairs Executive or Specialist to join a growing nutritional supplements and veterinary products company based in Lancashire. You will be a vital part of the businesses growth within local UK and international markets. You will be working with the Head of Regulatory Affairs Partner for the business and provided further development to enhance your career.
- You will provide regulatory knowledge on ingredients, product changes and maintenance issues.
- You will co-ordinate regulatory documents supporting product changes and registration in both the UK and international markets.
- Assist in training of staff in regards to any regulatory changes for mandatory revisions.
- Lead the organisations Pharmacovigilance requirements.
- You will provide appropriate summaries and options resulting from changes to regulations.
- You will prepare and process variations, product renewals for new and existing marketing authorisations.
- You will ensure all product labels, packaging and literature complies with the appropriate legislation for both UK and international markets, performing checks on all when appropriate.
- You will continuously conduct analysis on dossiers and update all regulatory documentation as required, produce dossiers and store correctly.
- Some travel maybe required to other sites, you will attend staff meetings and training courses as required.
- Will hold a degree within Life Sciences, preferably Pharmacy or Chemistry
- Must have at least 2 years' experience in Regulatory Affairs, within veterinary medicine or animal feed regulations would be a bonus.
- You will have experience working with regulatory bodies such as VMD or MHRA.
- You will have experience of product registration within international markets.
- Working knowledge of GMP / Good Manufacturing Practice, ideally within a Quality Department.
- You will have an understanding of the role of a Qualified Person within Pharmacovigilance / knowledge of veterinary products ( advantage )
- Excellent written and communication skills.
- Proven project planning skills.
- Experience dealing with external customers.
- Good Quality IT Skills and use systems such as; Microsoft Word, Excel, Power Point and Outlook.
Keywords: Regulatory Affairs, RA, veterinary medicine, animal feed, VMD, MHRA, GMP