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Regulatory Affairs Consultant CMC, Devices and Combination Products - UK based (remote/hybrid)

Contract: Permanent Career Opportunity

Closing Date: 31/07/24

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G&L is expanding our CMC team in Medical Devices, and we are looking for regulatory Affairs professionals with a background in devices and combination products.

The role holder would have primary responsibility for device and combination product strategy and would become the subject matter expert providing support to G&L project teams and client stakeholders. 

You would be responsible for ensuring regulatory compliance and efficient processes, participating in due diligence and in-licensing projects.

G&L has various projects across 2024 so we would like to hear from professionals who are planning a career move and would like to explore options.

The Role

Typical duties will include:

  • Responsible for regulatory submissions to worldwide health authorities including establishment and maintenance of regulatory files.
  • Submission planning including applying intelligence and developing regulatory strategy.
  • Preparation, maintenance, and submission of regulatory files including MAA/NDA/BLA, NBOp, CE, CTA/IND, Device File, Site Master File, renewals, post-approval changes, and commitments.
  • Accountable for planning and conducting regulatory interactions with health authorities including preparation of meeting requests, meeting packages, rehearsal, and taking minutes of formal meetings.
  • Provide input to affiliates for preparation for health authority interaction.
  • Responsible for Regulatory Due Diligence, including the assessment of product information, HA Interactions, CMC data package, and future development plans, critical regulatory issues, Risk Assessment, future business plan, and expected labeling versus competitor products if data available.
  • Accountable for the overall RA CMC/Device regulatory strategy, incl. DDC products.
  • Accountable for aligning with PS, affiliate, and GRL for timely progress of activities.
  • Inform leadership about business-critical decisions, resource constraints, and unforeseen events
  • Providing oversight to subject matter experts (SMEs) focused on Regulatory CMC device and combination product guidelines and regulations, including developing and coordinating relationships with Notified Bodies in Europe.
  • Developing and communicating strategic direction based on global regulatory guidelines and experience.
  • Collaborating with stakeholders across functional areas to develop and enhance business processes to ensure regulatory compliance and efficient processes.
  • Working effectively with stakeholders to understand functional interdependencies, assess the impact on effective processes, develop mutually agreed-upon optimized processes, and drive key cross-functional initiatives and business imperatives.

Requirements

Our ideal candidate would have:

  • Around 10 years of Regulatory Affairs experience, preferably multidiscipline.
  • Device and/or combination product-related experience is essential.
  • Knowledge of CMC regulatory requirements during development and post-approval phases, with emphasis on devices and combination products.
  • Ability to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects, and work independently.
  • Ability to identify, communicate, and resolve routine/complex issues.
  • Ability to identify trends and changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.
  • Excellent interpersonal skills, and the ability to thrive in a cross-functional environment. Confidence to speak up on issues and risks as well as on the good news.
  • Excellent computer skills, including the ability to utilize electronic systems for dossier creation and tracking.


G&L Consultants are known for being strong team players, who are confident to communicate their opinions, facts, and thoughts with clarity, transparency, and honesty.

We have high expectations of our colleagues, and our clients expect outstanding standards – both with results that are achieved, and also by looking for opportunities for continuous improvement.

You should be open-minded and agile, be interested in other’s opinions, and be ready to act on new information and differing perspectives.

How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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