Regulatory Affairs Manager

A global biotechnology company who are a market leader in their therapeutic area are looking for a Regulatory Affairs Manager with strong centralised product experience to join their team in London working on a launch of an innovative new product.

Working with the regulatory team, you will contribute to the development of regulatory strategies and submissions by providing strategic advice.

This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.

Key Responsibilities

• Developing and managing regulatory submissions such as Clinical Trial Applications (CTA), PIP applications, pre approvals and MAA
• Taking the lead on the regulatory lifecycle working closely with clinical development and commercial teams in a cross functional way
• Delivering strategic regulatory guidance in order to improve submissions development, you will be a subject matter expert and advice other teams on regulatory responsibilities
• Liaise with and build good relationships with regulatory agencies and other internal and external stakeholders

Requirements

• Previous experience in regulatory affairs/clinical development
• Centralised regulatory affairs experience
• Strong communication and interpersonal skills
• Industry experience in oncology or rare diseases highly advantageous
• Preferably a Life sciences degree
• Exposure of Regulatory Affairs legislation and submissions procedures such as CTA, PIP applications and MAA is advantageous
• Strong project management and leadership skills

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.