Regulatory Partner

1 month ago

Welwyn Garden City, Hertfordshire, United Kingdom Roche Full time
About Roche UK

We're a leading healthcare company that's passionate about delivering better outcomes to more patients, faster. Our mission is to transform the lives of millions of people, and we're committed to building a culture that's centered around growth mindset, prioritization, ownership, and accountability.

Our Commitments
  • Better outcomes to more patients, faster
  • Healthcare partners are 'wowed' when they work with us
  • Our innovations are faster and bolder
  • We provide services and products to better serve people
  • Purpose is our primary motivator
  • We spend our time contributing where it adds the most value
Our UK Operating Model

We're based on the following principles:

  • Flexible resourcing across fit-for-purpose teams to address specific needs and priorities
  • Healthcare-driven focus through outcomes
  • Consultation, individual empowerment & accelerated decision-making through decentralization
  • Customer focus through mutually beneficial partnerships
  • Collaboration
  • Transparent portfolio level prioritization
Regulatory Partner Expectations

The Regulatory group works with the wider business to translate the constantly evolving requirements of the UK Regulatory environment into Roche policies, procedures, solutions, and strategies that ensure compliance and maximum value to patients. As a Regulatory Partner with a medical devices background, you will be focused on supporting the delivery of our broad and innovative first-in-class combined drug/device portfolio.

  • Provide regulatory expertise on new product development and submission planning to project teams (Squads, Work Packages, etc.) to ensure optimal time to approval and continued regulatory compliance in maintenance of the lifecycle.
  • Drive and support MHRA interactions that concern combination and/or medical device product submission strategy.
  • Ensure that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature (physical devices, digital devices, in-vitro diagnostics, etc.).
  • Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
  • Provide support for the implementation/adaptation of the medical device structure across the UK Affiliate.
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
  • Advise the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concerns the UK.
  • Continuously monitor the changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new Regulations.
  • Be part of Trade Associations (ABPI, MedTech, etc.) working groups and gather regulatory intelligence.
  • Keep track of changes and/or implementation of regulations relevant to medical devices, such as (but not limited to) Sustainability/Environment, etc.
  • Provide training/mentorship and/or coaching support as required on medical device regulation and all its related aspects.
  • Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines.
  • Assess changes to existing products and company practices and provide an impact assessment, where necessary.
  • Review Marketing materials and provide advice to the commercial teams on business-related activities.
Who You Are
  • With a good understanding of the medical devices industry (desirable pharmaceutical/biotech industry) and experience working within a regulated environment, you are in pursuit of seeking greater depth and exposure to medical devices and combination regulatory strategies within the pharma sector.
  • An ability to understand scientific and technical information relating to an assigned portfolio of Roche products.
  • With a strong track record of working in matrix teams and a passion for problem-solving, you will contribute and/or lead to deliver innovative solutions to complex and/or ambiguous regulatory issues that impact the chapter and/or wider business.
  • You will have experience in developing or contributing to product-level plans and goals.
  • You will hold a scientific degree.

Please apply with a copy of your CV and a cover letter. Good luck with your application.

This role unfortunately does not offer relocation or sponsorship support.

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