Senior Regulatory Affairs Manager

A global biotechnology company who are a market leader in their therapeutic area are looking for a Senior Regulatory Affairs Manager with strong full cycle product management experience to join their team in London.

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)
• 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 advise 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 role particularly within the pharmaceutical industry
• Preferably a Life sciences degree and science advisory experience
• Exposure to Regulatory Affairs full cycle and submissions procedures such as CTA is advantageous
• Strong matrix management or project lead experience
• Ideally industry experience in rare diseases 
• Excellent communication and interpersonal 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.