Mary Bolt is recruiting for a Regulatory Affairs Manager to join our client, a successful consultancy at their site based in Harlow on a permanent basis.
Our client is a successful consultancy who provide end-end regulatory services across the product lifecycle for a wide range of clients.
The Location: Harlow
The role is based at our client's site in Harlow which is easily commutable from London and Hertfordshire, with offices located opposite the train station. Harlow offers everything from arts, culture and theatre to sport, parks and nature reserves
The main purpose of the role will be to:
· Write or review all types of variations, simple and complex
· Review and QC check documents for the Linguistic Review process
· Review updates to Summary of Product Characteristics and Patient Information Leaflets and outcomes
· Have detailed knowledge of current legislation associated with regulatory requirements
· Co-ordinate licensing and post licensing procedures on behalf of clients, i.e. Clinical Trial Applications, National, Mutual Recognition and Centralised Applications under senior staff guidance.
· Write regulatory plans, labelling texts, SOPs/ Processes and Module 2 and 3 documents
The candidate will be expected to provide leadership and execute the following:
· Assist the senior management team by line managing 2-3 members of staff and assigning workload priorities
· Be the point of contact for clients and regulatory authorities
· Lead National, Centralised and International Marketing Authorisation Applications and write sections of dossiers for MR, DP and CP's.
· Assist in providing regulatory knowledge to business development colleagues during bid reference
To succeed in this role, you will come from a background in:
· 2:1 (or above) graduate in relevant scientific discipline
· Extensive regulatory affairs experience
· In depth knowledge of all application types and a variety of therapeutic areas
· Understanding of Mutual Recognition, Decentralised and Centralised procedures
· Ability to work under pressure and achieve timely submissions and regulatory approvals
· Good computer skills
· Ability to analyse issues and provide solutions
25 days holiday + 8 days bank holiday, annual performance based bonus, a pension scheme
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL42795 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Mary Bolt
- Phone: 01438 743047
- Reference: CL42795
- Posted: 23rd July 2018
- Expires: 20th August 2018