about 1 month ago
Job title: Regulatory Affairs Manager UK/IE 12-month FTC
A Pharmaceutical business in Essex are seeking a Regulatory Affairs Manager to join on a 12-month fixed term contract. This role will focus on regulatory applications for the UK and IE portfolio.
- To submit regulatory applications for the UK/IE licence portfolio, expediting approvals as required meeting market demand.
- To work closely with manufacturing, QA, packaging testing, artwork origination and release sites, plus Medical and Pharmacovigilance departments, in order to support the preparation, compilation, review and submission of high-quality regulatory documentation
- To work closely with EU RA Competence Centres in order to provide timely UK/IE specific documentation
- To co-ordinate resource effectively to ensure that Regulatory approvals are secured in line with business timelines, and regulatory project support is provided
- Degree in life sciences/pharmacy or equivalent qualifications
- Significant experience in the Pharmaceutical Industry, including experience within EU or UK Regulatory Affairs
- Desirable to have UK, IE or other EU member state experience and knowledge of regulatory procedures
- Additional experience in R&D, Quality or Operations desirable.
Salary and benefits:
A highly competitive salary, annual bonus, private medical insurance and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org