Senior Regulatory Lead

6 hours ago


Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
Regulatory Affairs Leadership Opportunity

We are seeking an experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences.

Key Responsibilities:

  • Provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.
  • Develop and implement effective regulatory strategies to support drug development activities.
  • Prepare and submit regulatory documents, including orphan drug designation applications and clinical trial authorizations.
  • Cultivate strong relationships with regulatory authorities to ensure successful project outcomes.

About the Role:

  • This is a leadership position that requires a minimum of 12+ years of experience in Regulatory Affairs within a complex therapeutic area.
  • The ideal candidate will have extensive experience in early-stage drug development and be confident with UK, EU, and US health authorities and drug pathways.
  • A strong understanding of EMA procedures and ability to drive global Regulatory Affairs Strategies are essential.
  • The salary for this role is estimated to be £130,000 + Benefits, reflecting the importance of this position in our organization.

Benefits:

  • A competitive salary package, including benefits and bonuses.
  • The opportunity to work with a prestigious global drug development consultancy business.
  • A dynamic and collaborative work environment.

Requirements:

  • A B.Sc. in a life sciences subject and/or a higher degree preferably a PhD but this isn't essential.
  • Excellent written and verbal communication skills.
  • Able to negotiate and concisely express clear positions to stakeholders at all levels.
],

  • Cambridge, Cambridgeshire, United Kingdom Vivify Talent Full time

    Vivify Talent Overview:We're a small yet ambitious regulatory writing consultancy looking for a talented Principal Medical Writer to drive our projects forward. With a focus on flexibility and work-life balance, we offer a unique opportunity to excel in a fully remote role.As a key member of our team, you'll be responsible for leading the creation of...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Senior/Principal Medical WriterWe are currently looking for a Senior/Principal Medical Writer to join our team in the UK. As a key member of our clinical development team, you will be responsible for producing high-quality regulatory documents for the international pharmaceutical industry.About the Role:You will prepare a variety of clinical regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleIn this exciting role as Senior Associate, Regulatory Affairs, you will collaborate with internal colleagues and external organizations to support the timely execution of regulatory submissions, responses to questions, audits, and inspections. You will also be responsible for the maintenance of regulatory files and tracking databases, including...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Regulatory Affairs Labeling DirectorGilead Sciences International, Ltd. is seeking a highly experienced Senior Regulatory Affairs Labeling Director to lead the Global Regulatory Labeling team.Key Responsibilities:Develop and implement global labeling strategies to ensure compliance with evolving regulatory requirements.Lead a team of...


  • Cambridge, Cambridgeshire, United Kingdom Eclectic Recruitment Ltd Full time

    A competitive salary of £55,000 - £70,000 per annum is offered for this position.Eclectic Recruitment Ltd are working with a leading telecommunications company based in Cambridge to find an experienced Senior Regulatory Compliance Expert. This is a full-time permanent role with the option of hybrid working.Responsibilities include:Ensuring products meet...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

    Job Overview:At Gilead Sciences, we're dedicated to creating a healthier world for all people. We're seeking a skilled Senior Global Regulatory Affairs Manager to join our team and contribute to the development of life-changing scientific innovations.As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Regulatory Affairs Director Job OverviewWe are seeking a highly skilled Regulatory Affairs Director to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).About the RoleThis is an exciting opportunity to work with a...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job OverviewWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Key Responsibilities:Lead client projects, providing expert regulatory guidance...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Senior Manager to join our team at Gilead Sciences International, Ltd. in Cambridge, United Kingdom.Job SummaryThe successful candidate will be responsible for leading the development and implementation of regulatory strategies for CMC (Chemistry, Manufacturing, and Controls) activities in the...

  • Lead Aerospace Auditor

    10 hours ago


    Cambridge, Cambridgeshire, United Kingdom Morson Group Full time

    About the Opportunity:Morson Group is looking for a Senior Quality Assurance Professional to lead our quality audit team. As a key figure in our organization, you will be responsible for conducting audits, investigating quality failures, and providing assurance duties.Key Responsibilities:Conduct audits to ensure regulatory compliance and quality management...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job OverviewWe are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Bicycle Therapeutics. As a key member of our regulatory affairs department, you will be responsible for the development, execution, and tracking of global regulatory submissions for assigned programs or projects.


  • Cambridge, Cambridgeshire, United Kingdom Russell Taylor Group Ltd Full time

    Job DescriptionOur client, a leading household name in the Agrichemical and Horticulture industries, is seeking a highly skilled Technical Manager to join their team. As a key member of the organization, you will be responsible for leading new product development projects, building relationships with suppliers, and ensuring regulatory compliance.About the...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Company Overview:Bicycle Therapeutics is a clinical-stage pharmaceutical company pushing the boundaries of drug development. With a focus on novel therapies, they aim to revolutionize the treatment of underserved diseases. Our team is driven by a passion for innovation and a commitment to delivering high-quality medicines.Salary:$200,000 - $250,000 per...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Company Overview:Bicycle Therapeutics is a dynamic pharmaceutical company committed to delivering innovative treatments for challenging diseases. Our team is driven by a passion for innovation and a commitment to excellence.Salary:$220,000 - $270,000 per yearJob Description:We are seeking a seasoned Regulatory Affairs Director with Strategic Expertise to...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Cpl Life Sciences is seeking a highly experienced Lead Regulatory Affairs Specialist to join our team in Cambridge, UK. This is a unique opportunity to work with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities.The successful candidate...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Job Title: Compliance OfficersEstimated Salary: $85,000 - $110,000 per year.Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative treatments for complex diseases. As a Senior Associate in Regulatory Affairs, you will play a critical role in shaping the company's regulatory strategy, ensuring compliance with global...


  • Cambridge, Cambridgeshire, United Kingdom Mundipharma International Full time

    Job OpportunityWe are currently seeking a senior manager to lead our regulatory systems and data management function.This full-time position is based in Cambridge with the possibility of hybrid or flexible work arrangements.The ideal candidate will have extensive experience in regulatory operations, data management, and system governance, along with a strong...


  • Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full time

    Quality Assurance and Regulatory Affairs LeadReed Engineering has partnered with an industry leading Biotech at the forefront of diabetes research. My client has an immediate requirement for someone to lead the quality and regulatory projects and functions. You will maintain and improve robust quality management systems and ensure adherence to regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Toni Group, LLC Full time

    Toni Group, LLC Seeks Experienced LeaderWe are seeking a seasoned Senior Pharmacometrician to lead our team in drug development.Job OverviewThis is a unique opportunity for a highly skilled pharmacometrician to take on a leadership role and contribute to the success of our projects.SalaryThe estimated annual salary for this position is $120,000 - $160,000...


  • Cambridge, Cambridgeshire, United Kingdom ELP Consult Ltd. Full time

    At ELP Consult Ltd., we are seeking an experienced Compliance Officer to join our team. This role is a critical part of our organization, and we need someone who can ensure that our operations comply with regulatory requirements and internal policies.Job SummaryWe are looking for a skilled Compliance Officer who can oversee and implement our compliance...