Current jobs related to Regulatory CMC Consultant - United Kingdom - ProPharma

  • 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 - 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...

  • 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...

  • 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...

  • 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...

  • Associate Director Regulatory Affairs

    1 week 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...

  • Director, Regulatory Affairs

    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...

  • Director, Regulatory Affairs

    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...

  • Regulatory Writer

    4 weeks ago

    United Kingdom SRG Full time

    Job Title: Dossier Development Scientific Writer Type: 6 Month temp – Potential to extend Location: Hull, England, Hybrid – Remote working is possible for the right candidate. SRG is currently working exclusively with a global specialty pharmaceutical company that is dedicated to transforming addiction from a global human crisis to a recognized...

  • Regulatory Writer

    4 weeks ago

    United Kingdom SRG Full time

    Job Title: Dossier Development Scientific Writer Type: 6 Month temp – Potential to extend Location: Hull, England, Hybrid – Remote working is possible for the right candidate. SRG is currently working exclusively with a global specialty pharmaceutical company that is dedicated to transforming addiction from a global human crisis to a recognized...

  • CMC Development Manager

    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 Manager will support the CMC and clinical operation teams. This is a start up environment, the post holder will have a high degree of...

Regulatory CMC Consultant

4 months ago

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, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Job Description

  • Regulatory CMC writing of pharmaceutical quality documentation (CTD-Modules 2.3 & 3, IMPD, ASMF)
  • Provide strategic regulatory advice in regards to pre- and post-approval issues to clients
  • Conduct due diligence and gap analysis of existing products on behalf of clients.
  • Prepare and submit applications for marketing authorisations and variations including responses to deficiency letters for human medicinal products
  • Communicate with regulatory authorities, manufacturing sites, API manufacturers and quality control laboratories.
  • Support technology transfer projects from a regulatory affairs perspective.
  • Keep yourself updated about changes or developments in the regulatory affairs guidelines.
  • Maintain and build client relationships

Qualifications

  • Ph.D. in Chemistry, Biochemistry, Biotechnology or Pharmacy.
  • Proven experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs.
  • Excellent understanding of the pharmaceutical product life cycle.
  • Extensive experience in preparing documentation for regulatory authorities.
  • Ability to maintain high quality, accuracy and consistency in your work and deliver on your commitments.
  • Willing to undertake business travels to clients and other ProPharma sites.
  • Positive attitude and are able to work well within a team.
  • Able to work independently with less supervision, take initiative and make decisions based on company guidelines.
  • Able to work on multiple projects, prioritize and meet project deadlines.
  • Excellent communicator and have the ability to work with all levels of the company.

If you're an experienced regulatory professional who is passionate about delivering exceptional service to clients and enjoys working in a fast-paced, dynamic environment, we want to hear from you. ProPharma offers a competitive salary, excellent benefits package, and opportunities for professional development and advancement. Apply today to join our team