My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Senior Regulatory Affairs Consultant...
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate on a 12 month contract to be based in their offices in Middlesex.
You will be required to help ensure that existing UK Product Licences are maintained and new Marketing Authorisations are obtained to allow continued and future sale of categories of Consumer Healthcare products in the UK. Ensure that all regulatory activity for a specified portfolio of products is planned and geared to commercial requirements.
- Support the Regulatory Affairs group with all general filing, archiving, and database maintenance and as well as departmental administrative requests.
- Support the Regulatory Affairs team for marketed and development products and to be aid in progressing the regulatory status of these products in UK & Ireland in such a manner as not to interfere with the marketing and the development activities of the business.
- Prepare submissions which are both accurate and high quality and ensure all files and databases are effectively managed.
- Be responsible with the support of a Regulatory Manager for advising marketing and GMS on the regulatory implications of technical changes
- Develop knowledge of the regulations and guidelines and working practices of the EC and UK & Ireland Regulatory Authority.
- Develop knowledge of PAGB Codes and advertising regulations for OTC medicines.
- Have some knowledge of the Medical Devices Directive, Cosmetics Directive and PIPs
- Help ensure that all pack copy complies with the MHRA and HPRA approved version and to manage instigation following an approval.
- Identifies, challenges, develops and implements written procedures (e.g. local SOPs, work instructions), and proactively highlights opportunities for process improvement.
- Degree minimum in Pharmacy, Chemistry or Life Science
- Ability to work under limited supervision and prioritise work load accordingly
- Demonstrate ability to show attention to detail
- Strong IT skills and ability to work with a variety of systems
- High learning agility, and has the ability and willingness to deal effectively with first-time situations or changing conditions.
- Be able to demonstrate highly effective oral and written communication skills at all times.
- Ability to partner, influence, network and negotiate with key internal / external stakeholders.
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srg.co.uk or 01753 589673