Regulatory Affairs Officer

REGULATORY AFFAIRS OFFICER, C£40000 + Good Benefits, Andover, Hampshire
1494/75/dh

REGULATORY AFFAIRS OFFICER - JOB ROLE: To provide Regulatory advice and support to the UK
Company's affiliate, with the ability to recognise potential impact of emerging issues. Responsible for presentation & accuracy of all prepared documentation. Accountable to Regulatory Affairs Manager.

REGULATORY AFFAIRS OFFICER: KEY RESPONSIBILITIES:
* Gain marketing authorisations for new pharmaceutical products in the UK
* Liaise with European Regulatory Affairs & Corporate groups on Regulatory issues.
* Provide Regulatory advice for new products
* Draft of packaging texts, SmPCs, PILs & Prescribing Information
* Review promotional material in accordance with Teh Prescription Medicines
Code of Practice Authority (PMCPA/ABPI Code
* Maintain awareness of current & new legislation/guidance & ensure work is in compliance
with statutory requirements.

REGULATORY AFFAIRS OFFICER: QUALIFICATIONS, SKILLS, EXPERIENCE:
* Life Science Degree or equivalent experience
* Extensive exp of working in a regulatory environment
* Competent Project Management skills
* Ability to thrive in a changing environment & to re-prioritise workload to meet business needs