Senior Regulatory Officer

Location

Huddersfield, West Yorkshire | United Kingdom

Job description

Overview

Senior Regulatory Officer 

Location: North West

Salary: competitive

An opportunity arisen to work for a well establish company in the NW area. This position involves supporting the development of a pipeline of generic pharmaceuticals

Responsibilities

• Liaise with the QA department and the manufacturing and development sites to get the required data to populate the dossier
• Provide strategic regulatory advice on development projects
  Prepare scientific advice requests and attend meetings with MHRA and other national competent authorities
• Write Module 1 and Module 3, Prepare Module 2, Prepare MAA (dossier)
• Liaise with clinical consultants to prepare the non-CMC parts of the dossier
• Prepare associated regulatory submissions
  Manage regulatory procedures at both EU and UK national level from application through to approval

Qualification and experience

• Successful candidate will have minimum BSc in Life Sciences, Chemistry or related discipline with 4 years’ experience in Regulatory affairs
  Good Knowledge of Clinical development activities would be desirable
  Experience with generic drug development programmes
  Pre and post marketing experience
  Strong communication skills (both written and orally)
• Attention to detail
• Efficient and timeline/target orientated
• Ability to work both independently and within a team

Skills: Regulatory Affairs, License maintenance, Life Science degree, Pharmaceuticals,  GMP, ISO 13485 etc.

To apply for this position, candidates must be eligible to live and work in the UK

Job tags

Salary