Regulatory Affairs Director

1 week ago


London, Greater London, United Kingdom Lifelancer Full time
Job Title: Associate Director Global Regulatory Affairs

The Associate Director Global Regulatory Affairs is a critical role responsible for ensuring regulatory objectives are met and aligned with Telix's corporate goals. This position plays a key part in developing and executing global regulatory strategies and dossier compliance for assigned products.

Key Responsibilities:
  • Develop and execute global regulatory strategies and submission requirements in collaboration with the regulatory affairs team.
  • Represent regulatory affairs on project teams, providing guidance and regulatory expertise to other departments to support product development.
  • Lead regulatory agency interactions, including coordination of briefing package preparation, meeting minutes, and responses to agency questions.
  • Prepare, review, and analyze pharmaceutical and technical information for regulatory submissions to health authorities.
  • Provide regulatory assessments for change management and ensure compliance of regulatory submissions by filing and/or coordinating regulatory amendments.
  • Monitor global health authority regulations, guidelines, and specifications to maintain regulatory submission compliance.
  • Lead regulatory interactions with health authorities for IND and BLA filings.
Requirements:
  • Undergraduate degree in a scientific field (chemistry, biology, pharmaceutical sciences) required; advanced degree preferred.
  • 7 years of experience in regulatory affairs for pharmaceutical products.
  • Direct experience in writing regulatory sections for global health authority applications.
  • Direct experience in radiopharmaceuticals, biologicals, and/or clinical preferred.
  • Comprehensive knowledge of drug development processes, biopharmaceutical technology, drug manufacturing processes, GMP, and related issues.
  • Ability to understand and interpret regional regulations, guidance documents, and common and scientific publications.
  • Experience working globally in the US and EMEA.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.

Please use the below Lifelancer link for job application and quicker response.

/jobs/view/aa1cc9d1f6586cf99fa2

Remote Work: No



  • London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...


  • London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...


  • London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...


  • London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...


  • London, Greater London, United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to drive and lead regulatory CMC strategy for a leading Biotech business through a CRO. This role will focus on working with one of their main partners in the EMEA region.Key Responsibilities:Develop and execute CMC...


  • London, Greater London, United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to drive and lead regulatory CMC strategy for a leading Biotech business through a CRO. This role will focus on working with one of their main partners in the EMEA region.Key Responsibilities:Develop and execute CMC...


  • London, Greater London, United Kingdom Lawton Senior Living Full time

    Job DescriptionJob Title: Regulatory Affairs DirectorJob Summary:We are seeking a highly experienced Regulatory Affairs Director to join our team at Lawton Senior Living. As a key member of our leadership team, you will be responsible for ensuring that our organization is in compliance with all relevant regulatory requirements and industry standards.Key...


  • London, Greater London, United Kingdom Lawton Senior Living Full time

    Job DescriptionJob Title: Regulatory Affairs DirectorJob Summary:We are seeking a highly experienced Regulatory Affairs Director to join our team at Lawton Senior Living. As a key member of our leadership team, you will be responsible for ensuring that our organization is in compliance with all relevant regulatory requirements and industry standards.Key...


  • London, Greater London, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionJob Title: Senior Manager/Director of Regulatory AffairsCompany: Pharma Partners Recruitment LtdJob Type: Full-timeIndustry: Food and NutritionLocation: LondonAbout the Role:We are seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for setting the...


  • London, Greater London, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionJob Title: Senior Manager/Director of Regulatory AffairsCompany: Pharma Partners Recruitment LtdJob Type: Full-timeIndustry: Food and NutritionLocation: LondonAbout the Role:We are seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for setting the...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Director - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Remote or On-SiteRemuneration: Attractive salary and packageCpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Director - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Remote or On-SiteRemuneration: Attractive salary and packageCpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle...


  • London, Greater London, United Kingdom MSD Full time

    Job Description**About the Role**We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD. As an Associate Director, Regulatory Affairs, you will play a key role in managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the team's defined...


  • London, Greater London, United Kingdom MSD Full time

    Job Description**About the Role**We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD. As an Associate Director, Regulatory Affairs, you will play a key role in managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the team's defined...


  • London, Greater London, United Kingdom MSD Full time

    Job DescriptionAbout the RoleWe are seeking an experienced Associate Director of Regulatory Affairs to join our team at MSD. As a key member of our Regulatory Affairs Department, you will play a critical role in ensuring the smooth operation of all registration activities across our defined responsibilities.Key ResponsibilitiesRegulatory Strategy and...


  • London, Greater London, United Kingdom Lifelancer Full time

    Regulatory Affairs Program DirectorAs a key member of the Regulatory Affairs team, the Regulatory Affairs Program Director plays a pivotal role in translating regulatory strategies into actionable programs. This role is responsible for developing and executing key CooperVision RA and RA-driven cross-functional projects globally.Key Responsibilities:Provide...


  • London, Greater London, United Kingdom Lifelancer Full time

    Regulatory Affairs Program DirectorAs a key member of the Regulatory Affairs team, the Regulatory Affairs Program Director plays a pivotal role in translating regulatory strategies into actionable programs. This role is responsible for developing and executing key CooperVision RA and RA-driven cross-functional projects globally.Key Responsibilities:Provide...


  • London, Greater London, United Kingdom Willow Resourcing Limited Full time £50,000 - £60,000

    Job Title: Senior Manager/Director of Regulatory AffairsJob Type: Full-timeLocation: Remote (UK)About the Role:We are seeking a highly experienced Senior Manager/Director of Regulatory Affairs to join our team at Willow Resourcing Limited. As a key member of our compliance team, you will be responsible for ensuring that our business operations are in line...


  • London, Greater London, United Kingdom Willow Resourcing Limited Full time £50,000 - £60,000

    Job Title: Senior Manager/Director of Regulatory AffairsJob Type: Full-timeLocation: Remote (UK)About the Role:We are seeking a highly experienced Senior Manager/Director of Regulatory Affairs to join our team at Willow Resourcing Limited. As a key member of our compliance team, you will be responsible for ensuring that our business operations are in line...


  • London, Greater London, United Kingdom GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory team, you will be responsible for developing and executing regional regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.Key ResponsibilitiesDevelop and implement...