Senior Regulatory Executive

Salary: Excellent Package

Business Type: Major Generic Pharmaceutical Company
Job Type: Regulatory Affairs
Location: Hampshire

Background:

THE COMPANY · One of the major Generic Pharmaceutical companies in the United Kingdom · Itself a wholly owned subsidiary of a research based multinational pharmaceutical company · Situated in Hampshire, one hours drive from London · Turnover of £26 million · Very active new product pipeline with some twenty eight new products planned for launch in 2002 and twenty five more in 2003 · Manufacturing out-sourced from quality specialists around the world · Research and Development conducted through partners outside Europe · New products sourced from Group HQ and nationally

Primary Duties:

• A key player in a small vibrant department of four within a head office location comprising some 30 staff
• Reporting to the Regulatory Affairs Manager
• Responsibilities Include :-

Compilation of National “Essentially Similar” MA applications

Compilation and submission of answers to MCA queries

Compilation and submission of Type 1 and Type 2 MA variations

Renewals

MRP applications (Incoming and Outgoing)

Working closely with Marketing, Sales, R&D and Technical Managers and expediting approvals through MCA staff

Qualifications:

Ability to work under pressure in a small working environment, covering a wide range of Regulatory Affairs activities. Preferably two to four years of direct experience in the RA field gained in UK or Europe.

To apply for this interesting position please send your CV (preferably as a Word document) to the advising Consultant John Scourfield.

Medius Recruitment
Legion House 38 Roman Way
Lechlade-on-Thames
Gloucestershire GL7 3BP

tel: +44 (0) 1367 253279
fax: +44 (0) 1367 250190

email: info@mediusrecruitment.co.uk