Regulatory Affairs Manager

Location

Hertfordshire | United Kingdom

Job description

As a Regulatory Affairs Manager based in the Hertfordshire area you will:

• Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories to ensure on-time launches, continued supply and the compliance of all products
• Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identifying potential problems or delays, and possible solutions, as they occur.
• Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
• Provide expertise and specialist knowledge to support the department. Provide mentoring and training to department in specialist areas, as required.
• Attend and contribute at meetings; proactively raise issues and collaborate effectively to propose solutions. Ensure company/regulatory decisions are disseminated to junior team members.
• Support Manager through participation in or leadership of project teams and in the development of strategies for regional initiatives. Work alongside the Regulatory Management group to roll-out these initiatives.
• Provide mentoring, training and day-to-day support for junior team members as directed by the Regulatory Manager.
• Support junior team members by reviewing data intended for submission and provide advice on deficiencies and issues, and in the preparation of regulatory strategies for new marketing authorisation applications / post-approval submissions.

Job tags

Salary

£60k - £67k per annum