Job Description

Required skills: Experienced, Senior Regulatory Affairs Manager, West London/Home based

Senior Regulatory Affairs Manager \xe2\x80\x93 West London/Home based

Our client\xe2\x80\x99s product portfolio demonstrates an exceptionally innovative and successful track record in the fields of Urology, Endocrine Oncology, Gastroenterology, Endocrinology (Growth) and Reproductive Health (Infertility and Obstetrics).

The common thread is that the Company remains focused on producing treatments that enable doctors to treat patients on the body\xe2\x80\x99s own terms.

They are now seeking a Senior Regulatory Affairs Manager who whilst working across all therapy areas of the company will be involved in a range of Regulatory Affairs and Pharmacovigilance activities. The role supports the UK and Ireland.

Main accountabilities include:

• To formulate sound regulatory strategies for products in the assigned therapeutic area(s) to support business goals
• To execute regulatory strategies by overseeing and supporting RA activities of products in the assigned therapeutic area(s) to ensure regulatory compliance and fast registrations
• To implement and provide the services of Global Electronic Regulatory Platform (GeRP) according to global and regional processes
• To support RA in achieving the pre-assigned milestones

Essential Skills & Experience:

• Regional regulatory affairs experience from a similar role in the UK Pharmaceutical industry
• Knowledge of international guidelines and national legislation related to drug registration and Pharmacovigilance.
• Capable of developing and implementing regulatory strategy.
• Excellent communication and organisational skills
• Ability to critically assess data
• Attention to detail with strong IT skills
• Good scientific and medical writing skills

A Highly Competitive Basic and Benefits package will be paid.

Please apply online or contact CHASE for further information on 0131 553 6644.

Reference Number: 33498

Job Reference: 33498_1695362533

Pharmafield