Senior Regulatory Affairs Executive

Due to continued expansion we are currently seeking an additional Senior Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space.

This position requires a minimum of five years experience working in pharmaceutical regulatory affairs with knowledge of the drug development process, eCTD Dossier preparation, submissions management, and other regulatory functions. You will have the ability to work independently with minimal supervision as well as in a team and have an eye for detail with respect to documentation.

The position involves supporting the activities within the Regulatory areas of the company including drug safety and licensing of medicines.

You will have a degree in Life Sciences, Chemistry, Applied Biology or Pharmacy, excellent communication and negotiation skills, together with the ability to work independently.

Key Duties and Responsibilities

• Lead the preparation and submission of regulatory submissions, including marketing authorization applications, variations, and lifecycle management activities, ensuring alignment with EMA and MHRA requirements.
• Preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new licence applications, variations, PIQ submissions, responses to questions and renewals.
• Develop and execute regulatory strategies tailored to the European and UK markets, ensuring timely product registration, approval, and post-market compliance.
• Writing sections of the Module 3 of dossiers and Quality Overall Summaries
• Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. Coordination and review technical documentation.
• Collaborate closely with internal stakeholders, including Pharmacovigilance and Quality teams to align regulatory objectives and support business goals.
• Collaborate closely with client teams and internal consultants to deliver comprehensive regulatory solutions that meet business objectives and regulatory standards.
• Represent clients in interactions with European and UK regulatory agencies, including participation in regulatory meetings, responses to inquiries, and management of regulatory submissions.

Role Requirements

• Graduate in a Science based subject. Minimum of 5 years experience in Regulatory affairs.
• In-depth knowledge of European and UK regulatory requirements, procedures, and guidelines.
• Excellent verbal and written communication skills with high level of attention to detail and accuracy of work.
• Strong organisation skills and ability to cope with large volume of work across different areas of the company with changing deadlines.
• Strategic mindset with a focus on delivering value-added regulatory solutions and fostering long-term client relationships.
• Ability to work well both alone and as part of a team.

Behavioural Competence

• Customer Focus: Manages their own activities to ensure they are focussed on delivering outstanding service to the end customer.
• Teamwork: Can work well in a multi-disciplinary team and across teams to deliver requirements of role.
• Flexibility: Able to adapt to meet the needs of the business at any point in time.
• Problem-solving: Applies analytical thinking and creative problem-solving skills to overcome regulatory hurdles and deliver innovative solutions that drive client success.

Package Details

Competitive salary commensurate with experience, Annual performance related bonus, Contributory Pension, 25 days annual leave, East Midlands Office based but flexible working arrangements available.