Regulatory Affairs Consultant

7 days ago

Uxbridge, United Kingdom Parexel Full time

Regulatory Affairs Consultant - Medical Devices IVD/CDx (home or office based) Parexel Uxbridge, England, United Kingdom About The Role We are seeking an experienced Regulatory Affairs professional specializing in in‑vitro diagnostics (IVD) and Companion Diagnostics (CDx) to join our Global Regulatory Affairs team. In this strategic role, you will provide expert guidance on regulatory pathways for IVD and CDx development, clinical trials, and marketing authorizations while collaborating with cross‑functional teams and external partners. Key Responsibilities Develop and align global regulatory strategies for companion diagnostics across clinical trials, marketing authorizations, and lifecycle management. Collaborate with IVD and CDx partners and Clinical Measurement Sciences (CMS) teams to integrate regulatory considerations into IVD and CDx development plans. Ensure alignment between global and regional IVD and CDx regulatory strategies, involving local GRA teams as needed. Draft and review IVD and CDx‑related content for drug/device regulatory submissions. Lead or support regulatory agency interactions, including document preparation and meeting coordination. Manage IVD and CDx‑specific submissions (e.g., Performance Study Applications in the EU) and responses to agency queries. Provide comprehensive regulatory risk assessments and communicate risks to internal stakeholders. Serve as a subject matter expert on Global Project Team Regulatory Sub‑teams. Support IVD/CDx partner selection processes, due diligence activities, and contracting. Offer specialized regulatory consultation on IVD and CDx. Participate in cross‑functional and GRA initiatives to advance organizational objectives. Skills And Experience Required For The Role University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline. Minimum 5+ years of experience in Medical Device/IVD regulatory affairs. Extensive knowledge of international regulations for Medical Devices/IVD, with particular expertise in US and EU regulatory frameworks. Demonstrated experience with in‑vitro diagnostics and companion diagnostics regulatory pathways and regulatory submissions. Strong understanding of the drug‑diagnostic co‑development model. Experience working with regulatory agencies on IVD and CDx matters. Fluent in English, written and spoken. Experience also in medical devices and/or combination products would be a plus. Proficiency with regulatory systems including Veeva and TrackWise would be a plus. Seniority level Mid‑Senior level Employment type Full‑time Job function Business Development and Consulting Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care #J-18808-Ljbffr

  • Regulatory Affairs Consultant

    1 week ago

    Uxbridge, England, United Kingdom Parexel Full time £70,000 - £110,000 per year

    About The RoleWe are seeking an experienced Regulatory Affairs professional specializing on in vitro diagnostics (IVD) and Companion Diagnostics (CDx) to join our Global Regulatory Affairs team. In this strategic role, you will provide expert guidance on regulatory pathways for IVD and CDx development, clinical trials, and marketing authorizations while...

  • Remote IVD/CDx Regulatory Affairs Consultant

    18 hours ago

    Uxbridge, United Kingdom Parexel Full time

    A leading clinical research organization is seeking an experienced Regulatory Affairs Consultant to join their team in Uxbridge. This mid-senior level role focuses on in-vitro diagnostics and companion diagnostics, requiring expertise in regulatory pathways and strong collaboration with cross-functional teams. Ideal candidates have over 5 years of experience...

  • Regulatory Affairs Consultant

    2 weeks ago

    Uxbridge, United Kingdom Parexel Full time

    Regulatory Affairs Consultant - CMC biologics (home or office based)Parexel Uxbridge, England, United KingdomJoin or sign in to find your next jobJoin to apply for the Regulatory Affairs Consultant - CMC biologics (home or office based) role at ParexelContinue with Google Continue with GoogleRegulatory Affairs Consultant - CMC biologics (home or office...

  • Regulatory Affairs Consultant

    1 week ago

    Uxbridge, England, United Kingdom Parexel Full time £50,000 - £90,000 per year

    About The RoleWe are seeking an experienced Regulatory Affairs professional to lead our medical devices and combination products clinical trial regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for clinical investigations and serve as the key regulatory representative for our global project teams.The role can...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the region and make sure that...

  • Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom Park Street People Full time £125 - £150

    Role OverviewAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12‑month temporary contract. The role works closely with the regulatory team and core stakeholders across multiple areas, providing regulatory strategy and guidance to ensure deadlines and...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on an initial 12-month contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom CK GROUP Full time

    CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge or Cambridge on a on a contract basis for 12 months.**Salary**: Hourly: £45.56 PAYE or £60.35 Umbrella**Company**: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by...

  • Regulatory Affairs Associate

    1 week ago

    Uxbridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate to join a pharmaceutical organisation. This role is on a contract basis and is either located in Uxbridge or Cambridge. **Key Skills and Requirements**: - Familiarity in an administrative field within a corporate or similar setting preferably within a healthcare sector. - Educated to a degree...

  • Cmc Regulatory Affairs Associate

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    **Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Associate to join their team in Uxbridge.** Working in a busy global department, there is a focus on working together to achieve results. You would be joining a company with an exciting pipeline who are continually developing their drug portfolio. This is a...