job details for:
Regulatory Affairs - Regulatory Affairs Jobs - Berkshire

Regulatory Affairs - Regulatory Affairs Jobs - Berkshire (Job Ref: WR/JOBS/13234-5791)

Job Description :

Flame Pharma Regulatory Affairs - Regulatory Affairs Job - Berkshire:

Are you an experienced Regulatory Affairs professional looking for a more varied position within a Regulatory Affairs Consultancy? This is a fantastic opportunity to expand your skills and knowledge by joining one of the largest Regulatory Affairs consultancies in Europe.  Due to expansion, we are currently recruiting Regulatory Affairs professionals who will be responsible for managing various Regulatory Affairs projects for leading names in Pharmaceuticals on a full time basis.

Duties will include:

• Maintenance of marketing authorisations and licence variations and renewals.
• Preparation of high quality, detailed regulatory documents using varied information services.
• Compilation of relevant documentation to allow release of products.
• Assisting in the preparation and submission of regulatory applications.
• Collecting submission data and regulatory intelligence.
• Product line maintenance and New Product Licence applications.
• Ensuring that project work proceeds according to agreed deadlines and maintaining status records.
• Keeping up to date with international legislation, guidelines and customer practices.
• Understanding and evaluating complex information.
• Maintaining quality systems.

Skill Set:

• At least 2/3 years experience of regulatory affairs in the Pharmaceutical or Clinical Research sectors.
• Life sciences degree.
• Post-graduate qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage.
• Possession of first rate written and verbal communication skills.
• Demonstrate good working knowledge of IT  systems.
• Ability to work to strict deadlines under pressure.

Benefits:

This position comes with an attractive salary (from £32,500), plus bonus, healthcare, pension.

The position will be based in Berkshire.

For further details on this role please contact Flame Pharma today.