Current jobs related to Principle Regulatory CMC Consultant - United Kingdom - Barrington James

  • Associate Director Regulatory

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy.You will provide innovative...

  • Associate Director Regulatory

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy. You will provide innovative...

  • Associate Director Regulatory

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy. You will provide innovative...

  • Associate Director Regulatory

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy. You will provide innovative...

  • Associate Director Regulatory

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy.You will provide innovative...

  • Director of Regulatory Affairs CMC

    1 month ago

    United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory Affairs!Are you a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) with a passion for driving high-quality regulatory submissions? We're looking for a dynamic leader to steer multi-modality projects from development to commercialisation.Key Responsibilities:Lead the preparation and submission of CMC...

  • Director of Regulatory Affairs CMC

    4 weeks ago

    United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory Affairs! Are you a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) with a passion for driving high-quality regulatory submissions? We're looking for a dynamic leader to steer multi-modality projects from development to commercialisation. Key Responsibilities: Lead the preparation and submission...

  • Director of Regulatory Affairs CMC

    1 month ago

    United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory Affairs! Are you a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) with a passion for driving high-quality regulatory submissions? We're looking for a dynamic leader to steer multi-modality projects from development to commercialisation. Key Responsibilities: Lead the preparation and submission...

  • Director of Regulatory Affairs CMC

    1 month ago

    United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory Affairs!Are you a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) with a passion for driving high-quality regulatory submissions? We're looking for a dynamic leader to steer multi-modality projects from development to commercialisation.Key Responsibilities:Lead the preparation and submission of CMC...

  • Director of Regulatory Affairs CMC

    4 weeks ago

    United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory Affairs! Are you a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) with a passion for driving high-quality regulatory submissions? We're looking for a dynamic leader to steer multi-modality projects from development to commercialisation. Key Responsibilities: Lead the preparation and submission of CMC...

  • Principle Full Stack Engineer

    4 weeks ago

    United Kingdom CMC Markets Full time

    We are looking for an experienced Senior Full Stack Developer to work on a Customer Onboarding Vendor integration & Cloud Transformation project. Please note that this role will sit outside IR35. Overview CMC onboards retail customers from multiple global jurisdictions to trade on their proprietary trading platforms. Some of these jurisdictions, for...

  • Principle Full Stack Engineer

    4 weeks ago

    United Kingdom CMC Markets Full time

    We are looking for an experienced Senior Full Stack Developer to work on a Customer Onboarding Vendor integration & Cloud Transformation project. Please note that this role will sit outside IR35. Overview CMC onboards retail customers from multiple global jurisdictions to trade on their proprietary trading platforms. Some of these jurisdictions, for...

  • Principle Full Stack Engineer

    1 week ago

    united kingdom CMC Markets Full time

    We are looking for an experienced Senior Full Stack Developer to work on a Customer Onboarding Vendor integration & Cloud Transformation project. Please note that this role will sit outside IR35. Overview CMC onboards retail customers from multiple global jurisdictions to trade on their proprietary trading platforms. Some of these jurisdictions, for...

  • Principle Full Stack Engineer

    4 weeks ago

    United Kingdom CMC Markets Full time

    We are looking for an experienced Senior Full Stack Developer to work on a Customer Onboarding Vendor integration & Cloud Transformation project. Please note that this role will sit outside IR35.OverviewCMC onboards retail customers from multiple global jurisdictions to trade on their proprietary trading platforms. Some of these jurisdictions, for example...

  • Principle Full Stack Engineer

    4 weeks ago

    United Kingdom CMC Markets Full time

    We are looking for an experienced Senior Full Stack Developer to work on a Customer Onboarding Vendor integration & Cloud Transformation project. Please note that this role will sit outside IR35.OverviewCMC onboards retail customers from multiple global jurisdictions to trade on their proprietary trading platforms. Some of these jurisdictions, for example...

  • Principle Full Stack Engineer

    4 weeks ago

    United Kingdom CMC Markets Full time

    We are looking for an experienced Senior Full Stack Developer to work on a Customer Onboarding Vendor integration & Cloud Transformation project. Please note that this role will sit outside IR35. Overview CMC onboards retail customers from multiple global jurisdictions to trade on their proprietary trading platforms. Some of these jurisdictions, for...

  • CMC Development Contractor

    4 weeks ago

    United Kingdom Life Sciences Recruitment Full time

    LSR is working with an innovative diagnostics company that focuses on providing revolutionary molecular imaging technology for Oncology-focused patient care solutions. Reporting to the Head of CMC, the CMC Development Contractor will support the CMC and clinical operation teams. Development and management of outsourced therapeutic radiopharmaceutical CMC...

  • CMC Development Contractor

    1 month ago

    United Kingdom Life Sciences Recruitment Full time

    LSR is working with an innovative diagnostics company that focuses on providing revolutionary molecular imaging technology for Oncology-focused patient care solutions. Reporting to the Head of CMC, the CMC Development Contractor will support the CMC and clinical operation teams. Development and management of outsourced therapeutic radiopharmaceutical CMC...

  • Associate Director Regulatory Compliance

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy. You will provide innovative...

  • Associate Director Regulatory Compliance

    2 weeks ago

    United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMC Advanced Resource Managers are looking for an Associate Director of Regulatory Affairs - CMC to join our client who is a leading Biotech business through a CRO. This role will be solely working with one of their main partners focusing on driving and leading regulatory CMC strategy. You will provide innovative...

Principle Regulatory CMC Consultant

4 months ago

United Kingdom Barrington James Full time

An exceptional opportunity awaits with our client, a dynamic Regulatory Affairs Consultancy with a presence in the UK, Switzerland, and Ireland, serving global clients. In this role, you will join a team of seasoned experts in Regulatory, CMC, Clinical, and Non-Clinical fields, leveraging your CMC and Regulatory expertise to provide comprehensive support and guidance to clients throughout the product development lifecycle.


The ideal candidate will have a proven track record of delivering top-notch regulatory advice and support to both internal and external stakeholders. Experience with innovative biological products is essential, and a background in vaccines, ATMPs, or previous experience with FDA/EMA/National regulatory authorities is highly desirable. The successful candidate will possess a solution-oriented mindset, a proactive attitude, and the ability to think creatively to achieve optimal outcomes for clients and products.


Qualifications (Senior Consultant)


A minimum of a Master’s degree; PhD or Pharmacy degree preferred.

At least 3-5 years of regulatory experience in the industry, with significant experience with EU and US Regulatory Authorities strongly preferred.

Fluency in English is required; proficiency in an additional European language is an asset.

Excellent written and verbal communication skills.

Advanced analytical thinking with a solution-focused approach.

Collaborative and forward-thinking attitude.

Proven consulting skills desirable (training available).

Advanced Microsoft IT skills (training available). Previous experience with industry document management systems is highly desirable.


Responsibilities (Senior Consultant)


Provide CMC advice and support on client engagements for both biological and small molecules, including innovative and first-in-class products.

Support CMC regulatory activities such as dossier authoring (IND/IMPD, MAA/NDA Module 3), preparation of Scientific Advice briefing documents, and responses to Requests for Information. Lifecycle maintenance activities.

Gather and process data, collaborating with technical functions within client organizations to generate necessary submission documents.

Offer regulatory and strategic advice to address issues raised by Regulatory Authorities.

Prioritize tasks effectively, remaining agile and responsive to changing and conflicting priorities.

Deliver high-quality work that exceeds client expectations.

Proactively seek opportunities to develop and enhance professional skills.

Take initiative and actively seek out solutions aligned with client business needs.

Contribute to thought leadership activities, including attending conferences, authoring journal and website articles, and expanding the client database.


Qualifications (Principal Consultant)


All qualifications of a Senior Consultant, with at least 10-15 years of industry experience, including time spent within a National Competent Authority, FDA, or EMA.

Proven business development skills with a track record of creating or developing client relationships.

Experience advising senior leadership within client organizations (e.g., CEO, CSO, COO).

Strong understanding of the challenges faced by smaller biotech companies in early development (Proof of Concept to Phase 2).

Ability to tailor advice to client constraints, navigating regulatory requirements to streamline development activities.

Willingness to travel within Europe occasionally (