Pharmaceutical Regulatory Executive required for rapidly expanding team in Global Bioscience. Based Bristol. Salary dependant on experience.

Our client is a leading European consultancy company providing specialist product development and registration services to the global bioscience industries seeking product authorisations in Europe.

They have more than 140 years cumulative experience of working within the bioscience industries and Cyton prides itself in harnessing this depth of experience to provide innovative solutions in product development and regulatory affairs.

Key aspects of the role:

? Preparation of Part IA (veterinary medicinal products) and Parts 1.1 and 1.2 of Module 1 (human medicinal products) of all Marketing Authorisation Applications.
? Planning and managing all types of Regulatory Procedures (including those dealt with by the European Commission and its Agencies and by National Regulatory Authorities) carried out by the company on behalf of client companies.
? Liaising with Regulatory Authorities and client companies to permit timely completion of all Regulatory Procedures including updating documents as required during regulatory procedures and tracking issue of marketing authorisations.
? Assembling, copying and submission of regulatory dossiers and documentation to regulatory authorities in the European Union.
? Management of payment of fees to regulatory authorities on behalf of client companies.
? Provision of information about regulatory procedures to colleagues within the company and to client companies.

Ideal Candidates will have:

? Qualification in pharmaceutical or biological discipline.
? Experience in pharmaceutical development or regulatory affairs.
? Excellent analytical and writing, communication and negotiation skills.
? Excellent knowledge of standard MS Office applications.
? Perfect command of English, working knowledge of another European language.
? Ability to contribute to the functioning of a close-knit, working team.

To apply, please send your CV ASAP.

Additional Resources is an employment business and an employment agency as defined within the Conduct of Employment Agencies and Employment Business Regulations 2003