About the job

About the Company

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:

o Scientific Advice meetings,

o PIPs o Orphan Drug designations (ODDs).

o New Registrations via National or Centralised Procedure.

o Life-cycle management. o Implementation of EU Regulatory Strategy to maintain the organisation's existing product licences, and to integrate newly approved products into the portfolio.

o Management of overseas Affiliates and other Partners.

o preparing or authoring commercial and post approval submissions.

o 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:

o Registrations and Post marketing activity; CTD/Dossiers for MAAs (ideally, knowledge of all Modules 1 to 5).

o National Submissions and Centralised Procedure.

o Post marketing: Type Ia, Ib and II variations and renewals; labelling, PILs and SmPCs. o RTQs with EMA and MHRA.

•  Practical experience in interacting with