Quality , Science, Pharmaceutical & Food

Regulatory Affairs Project Manager

  • Contract
  • Remote
  • Southern England
  • 41931569

PE Global is currently recruiting for a Regulatory Affairs Manager for a leading multi-national pharmaceutical client based in Wokingham.


This is an initial 18 month contract with the possibility of future extensions for the right candidate. With expertise in Regulatory Affairs, this role will proactively coordinate the regulatory strategy deliverables for MedTech UK/IRE and liaise with the relevant stakeholders to allow the overall successful delivery of compliant Technical Documentation and UKCA Marking.


Role:

  • Utilizing the expertise within the Regulatory organization, develops and co-ordinates execution of the strategies for the program to align with expectations.
  • Drives consistency across all platforms across Medical Devices for technical documentation creation and adherence to procedures.
  • Develops and maintains constructive and cooperative working relationships with business functions in the organization.
  • Establishes and leads regulatory objectives to identify and deliver all required regulatory project activities.
  • Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule and resource model.
  • Working across the businesses and franchises, develops solutions and aligns on regulatory strategies with an emphasis on an ability to work with SMEs in labelling, quality and regulatory compliance.
  • Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges and process improvements throughout the program.
  • Identifies and facilitates continuous improvement activities.
  • Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams.
  • Educates franchise Associates on UK regulations and requirements and integrating those requirements into franchise shared procedures.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.


Requirements:

  • Bachelor’s degree with 5-8 years of experience or PhD, Pharm, Masters, legal degree with adequate experience required. Advanced degrees and education in medicine, engineering, science or law preferred.
  • Adequate experience in EU regulatory requirements for medical devices required.
  • Experience of managing Projects with team members in several different locations, acted as a PMO
  • Travel: Up to 10% travel may be required


Interested candidates should submit an updated CV.

Please click the link below to apply or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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