Regulatory Affairs Associate

Regulatory Professionals
West Heath
29 Sep 2017
02 Nov 2017
Contract Type
Full Time
Regulatory Affairs Associate Location: Wiltshire Salary: Up to £35,000 + 25 days holiday, bonus, pension, healthcare Ref: J30866 Regulatory Professionals are working with an international pharmaceutical company who have over 20 years of expertise and are still rapidly growing. They have a brilliant structured development plan, designed to provide you with the best chance of personal and professional progression, as well having a wide ranging product field so you can gain a scope of experience across multiple areas. The successful applicant will manage all the clinical labelling aspects of Regulatory Affairs. This role is located in a fast paced environment with multiple projects on the go at once and requires a dynamic, flexible and resourceful individual. The main responsibilities are as follows: *Management of all the clinical labelling aspects of Regulatory Affairs. *Responsible for the composition, conservation and QC of product information. *Providing input for Departmental QMS activities. *Dealing with authorities based in the EU. *Reviewing and coordinating CCDS, SmPC and labelling variations. The ideal candidate will possess the following qualifications and experience: *Have achieved a life sciences degree or equivalent. *At least two years of Regulatory Affairs experience. *Must have reviewed CCDS in the past. *Experience of the EU market and authorities. *Must have authored and analysed SmPCs and PILs. *Labelling variation. *Article 31 updates and PSUR experience highly desirable. In addition to the above, fantastic time management and prioritising skills will ensure you are successful in this role, combined with an ability to work effectively under pressure. If this isn't the role for you but you have someone to recommend, let us know and you will be rewarded with a £250 voucher of your choice in the event of a successful placement of your referral. Wiltshire, Oxfordshire, Berkshire, Hampshire, Gloucestershire, labelling, CCDS, SmPC, regulatory affairs, EU, Europe, associate.