Regulatory Affairs Officer (Pharma)

Meridian Business Support Limited
12 Jun 2017
25 Jun 2017
The Company: A growing manufacturer in Somerset is looking to recruit an experienced Regulatory Affairs Specialist with previous experience within a pharmaceutical / Animal Feed or similar production environment. Job Responsibilities: - Ensuring the company's products comply with regulatory requirements. - Keeping up to date with appropriate national, European and international legislation, guidelines, industry norms and customer practises. - Collecting, collating and evaluating scientific data that has been researched by colleagues. - Developing and writing clear justifications and explanations for product dossier registrations and renewals. - Advising management, colleagues and suppliers on regulatory requirements. - Project managing the compilation and writing of product dossiers typically in a CTD format. - Project managing the compilation and writing of NHCR dossiers and Feed Additive authorisation dossiers. - Involvement in regulatory inspections. - Liaising with regulatory authorities. - Work towards representing the company on regulatory boards/consortiums. - Overall responsibly for customer product registration enquires Preferred Skills: - Degree or equivalent in chemistry, biochemistry, pharmacology or similar preferred. - Masters or equivalent in Regulatory Affairs is desirable. - Pharmaceutical experience preferred. - At least 2-3 years experience in Regulatory Affairs Assistant/Advisor roles. - Knowledge of NHCR (Nutritional Health Claim Regulations) and Feed Additive authorisation requirements would be of benefit. Associated Benefits: - Competitive salary - Excellent benefits package Working Hours: 8.30 - 5pm, Monday to Friday. To apply, or to find out more information, please click on one of the "apply" buttons Please note that due to a high level of applications, we can only respond immediately to applicants whose skills & qualifications are suitable for this position. Meridian Business Support is acting on behalf of our Client as a Recruitment Agency.