I am partnering with a Mid sized Pharmaceutical client who are looking for a Regulatory Affairs Manager on a permanent basis working from their new Offices in Berkshire, the ideal person will have Health authority experience and has been involved in national route submissions. This is a really great opportunity to be part of a high performing team and an exciting time to be joining the business with several new products coming to market
Submissions:
- Leading development of MHRA regulatory documents and meetings.
- Coordination of all necessary regulatory affairs activities, in particular approval and maintenance. Project lead and manage all OPUK Regulatory activities, for example:
- Scientific Advice meetings,
- PIPs o Orphan Drug designations (ODDs).
- New Registrations via National or Centralised Procedure.
- Life-cycle management. Implementation of EU Regulatory Strategy to maintain the organisation's existing product licences, and to integrate newly approved products into the portfolio.
- Management of overseas Affiliates and other Partners.
- preparing or authoring commercial and post approval submissions.
- representing the company in communications and meetings with health authorities.
Management:
- Advising EU and UK regulatory considerations in developing strategy.
- Planning skills for: o regulatory submissions (MAAs) for products. o preparing forecasts for resource requirements o providing areas of improvement for products, processes, or services.
- Providing regulatory direction on regulatory mechanisms to optimise product registration.
- Serve as a CTD strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with minimal supervision for .
- Ensuring regulatory databases and trackers are maintained by the Regulatory team.
- Attend and manage internal and external meetings as required, to influence and drive the regulatory requirements of forward.
- Responsible for managing internal audits for the affiliate, to evaluate the compliance to local regulatory requirements, and corporate requirements.
Corporate image and Compliance:
Competencies / Other Requirements
Bachelor's degree or higher in Life Sciences or technical field and around 8 years of experience in a similar role.
Autonomous and independent work, hands-on
Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
Technically, you will have good working knowledge and experience of:
- Registrations and Post marketing activity; CTD/Dossiers for MAAs (ideally, knowledge of all Modules 1 to 5).
- National Submissions and Centralised Procedure.
- Post marketing: Type Ia, Ib and II variations and renewals; labelling, PILs and SmPCs.
- RTQs with EMA and MHRA.
Practical experience in interacting with
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Head of Regulatory Affairs in Reading employer: Parkside Recruitment
Join a forward-thinking international company that values integrity, professionalism, and a balanced approach to employee relations. With a strong emphasis on employee growth and a supportive work culture, this role offers the unique advantage of remote flexibility transitioning to hybrid working, allowing you to maintain a healthy work-life balance while contributing to meaningful organizational change. As an HRBP, you'll have the opportunity to work closely with leadership, ensuring your voice is heard and your contributions are valued in a dynamic environment focused on practical solutions.
