Head of Regulatory Affairs

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

#J-18808-Ljbffr…