Principle Regulatory CMC Consultant

3 weeks ago

London, 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.nAt least 3-5 years of regulatory experience in the industry, with significant experience with EU and US Regulatory Authorities strongly preferred.nFluency in English is required; proficiency in an additional European language is an asset.nExcellent written and verbal communication skills.nAdvanced analytical thinking with a solution-focused approach.nCollaborative and forward-thinking attitude.nProven consulting skills desirable (training available).nAdvanced 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.nSupport 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.nGather and process data, collaborating with technical functions within client organizations to generate necessary submission documents.nOffer regulatory and strategic advice to address issues raised by Regulatory Authorities.nPrioritize tasks effectively, remaining agile and responsive to changing and conflicting priorities.nDeliver high-quality work that exceeds client expectations.nProactively seek opportunities to develop and enhance professional skills.nTake initiative and actively seek out solutions aligned with client business needs.nContribute 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.nProven business development skills with a track record of creating or developing client relationships.nExperience advising senior leadership within client organizations (e.g., CEO, CSO, COO).nStrong understanding of the challenges faced by smaller biotech companies in early development (Proof of Concept to Phase 2).nAbility to tailor advice to client constraints, navigating regulatory requirements to streamline development activities.nWillingness to travel within Europe occasionally ( Responsibilities (Principal Consultant)

All responsibilities of a Senior Consultant, plus:nTake an active role in business growth by creating, leading, and managing client relationships.nLead and manage multi-functional (Clinical, Non-Clinical, CMC, Regulatory) Subject Matter Expert teams to deliver client engagements.nLead CMC development activities on behalf of clients, integrating seamlessly into their teams to deliver CMC programs in collaboration with clients, CROs, and CDMOs.nConduct technical due diligence on client assets for both buy and sell sides, advising on communication strategies and risk management.nCoach and mentor less experienced colleagues in areas of expertise.

Our Offer

A supportive and collaborative environment with opportunities for professional development.nAn outstanding opportunity to join a small consultancy and contribute to its growth.nA home-based role with high flexibility.nA competitive salary commensurate with experience.nAn excellent bonus scheme.

  • Principle Regulatory CMC Consultant

    5 days ago

    London, Greater London, 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...

  • Principle Regulatory CMC Consultant

    3 weeks ago

    London, 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...

  • Regulatory Cmc Consultant

    2 weeks ago

    London, United Kingdom Proclinical Full time

    Proclinical are recruiting a Regulatory CMC Consultant for a pharmaceutical organisation. This role is on a contract basis and is located in West London. **Responsibilities**: - Accountable for highlighting possible delaying factors promptly to line management as well as share knowledge of regulatory documentation and processes with others. - You will...

  • Regulatory CMC Consultant

    5 days ago

    London, Greater London, United Kingdom Barrington James Full time

    Job Description Regulatory CMC Consultant Join an unprecedented team, supporting a range of different projects. In this role, you will be driving a number of projects, including developing the eCTD for BLA filngs of Biologicals. Responsibilities: Represents the department on multi-functional project development teams to support regulatory filings ...

  • Cmc Regulatory Affairs Consultant

    4 days ago

    London, Greater London, United Kingdom G&L Healthcare Full time

    We are an industry-leading independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.As demand for our services and solutions continues to grow we are looking for a CMC consultant to join our team of Regulatory Affairs professionals on...

  • Senior Regulatory Cmc Consultant

    2 months ago

    London, United Kingdom Proclinical Full time

    Proclinical are recruiting a Senior Regulatory CMC Consultant for a pharmaceutical establishment. This role is on a contract basis and is located in London. The client is focused on developing remedies with transformative possibilities for cancer. **Responsibilities**: - Accountable for highlighting possible delaying factors promptly to line management, as...

  • Senior Regulatory Cmc Consultant

    3 weeks ago

    London, United Kingdom Proclinical Full time

    Proclinical are recruiting a Senior Regulatory CMC Consultant for a pharmaceutical establishment. This role is on a contract basis and is located in London. The client is focused on developing remedies with transformative possibilities for cancer. **Responsibilities**: - Accountable for highlighting possible delaying factors promptly to line management, as...

  • Cmc Regulatory Affairs Consultant

    2 weeks ago

    London, United Kingdom G&L Healthcare Full time

    We are an industry-leading independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions. As demand for our services and solutions continues to grow we are looking for a CMC consultant to join our team of Regulatory Affairs professionals...

  • Senior Cmc Consultant

    4 weeks ago

    London, United Kingdom Cpl Life Sciences Full time

    **Reference Number**: JO-2212-507068 Senior CMC Consultant **Rate**: Negotiable **Job Type**: Permanent **Location**: Central London / West End Senior Regulatory CMC Consultant Remote CPL Life Sciences are collaborating with a global pharmaceutical business company focused on the discovery, development, and commercialization of innovative...

  • Regulatory Cmc Associate

    4 days ago

    London, Greater London, United Kingdom ProClinical Full time

    Salary:Highly CompetitiveJob type:ContractDiscipline:CMCLocation:United Kingdom- London, England Posting date: 14 Mar 2024Reference:59472Proclinical is seeking a Regulatory CMC Associate for a 12-month contract role. This position will provide support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory...

  • Regulatory Manager

    2 months ago

    Uxbridge, Greater London, United Kingdom Parexel Full time

    Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the CMC Regulatory Manager, you will play a vital...

  • Regulatory Manager

    4 weeks ago

    Uxbridge, Greater London, United Kingdom PAREXEL Full time

    Regulatory Manager - CMC biologics (various European locations) This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our...

  • Associate Director, Regulatory CMC

    5 days ago

    London, Greater London, United Kingdom ProPharma Full time

    ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance,...

  • Associate Director, Regulatory CMC

    5 days ago

    London, Greater London, United Kingdom ProPharma Full time

    ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance,...

  • Associate Director, Regulatory CMC

    3 weeks ago

    London, United Kingdom ProPharma Full time

    ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance,...

  • Associate Director, Regulatory CMC

    4 weeks ago

    London, United Kingdom ProPharma Full time

    ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance,...

  • Regulatory Cmc Associate

    2 weeks ago

    London, United Kingdom ProClinical Full time

    **Salary**: Highly Competitive Job type: ContractDiscipline: CMC**Location**: United Kingdom- London, England - Posting date: 14 Mar 2024 Reference: 59472 Proclinical is seeking a Regulatory CMC Associate for a 12-month contract role. This position will provide support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for...

  • Regulatory Affairs Manager

    4 weeks ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time

    Job Description Regulatory Affairs Manager CMC Duration: 6 month Contract Inside IR35 Location: Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependent on experience. This role focuses on the critical aspect of Chemistry, Manufacturing, and Controls (CMC) within regulatory affairs. Responsibilities include: Leading global regulatory...

  • Associate Director Global Regulatory CMC

    3 weeks ago

    London, United Kingdom Discover International Full time

    Our Clientis a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines.nPosition Summary:nThe...

  • Regulatory Affairs CMC Manager

    3 weeks ago

    Uxbridge, Greater London, United Kingdom Cpl Life Sciences Full time €45 - €55

    Job Title: If your skills, experience, and qualifications match those in this job overview, do not delay your application. Regulatory Affairs CMC Manager Job Type: 6-Month Contract (inside IR35) Location: Uxbridge or Cambridge – 1 day on-site per month Rate: £45 to £55 per hour (PAYE) An exciting opportunity to join a leading global pharmaceutical...