Regulatory Affairs Strategist for Global Pharmaceutical Projects

1 month ago


Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
Job Description

MoonLake Immunotherapeutics is seeking a skilled Regulatory Affairs Strategist to develop and deliver innovative global regulatory strategies for sonelokimab lead indication(s). This role will be an integral part of our team, responsible for regulatory aspects related to product development and approval.

We are looking for a candidate with a minimum of 7 years of experience within regulatory affairs in the pharmaceutical industry or Biotech industry, ideally in a relevant disease area. The ideal candidate will have experience in nonclinical development, including designing pharmacology, pharmacokinetic, and toxicology studies.

A key requirement for this role is the ability to create and implement innovative regulatory strategies, understand and clearly communicate on topics of basic science, and work effectively in a highly complex and fast-paced environment. Our successful Regulatory Affairs Strategist will be proactive, using solid communication and influencing skills to execute program goals.

This is a fantastic opportunity to contribute to ground-breaking projects that have the potential to transform global healthcare. As a member of our team, you will have the chance to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

The estimated salary for this position is $120,000 - $180,000 per year, depending on location and experience.

Requirements
  • Minimum of 7 years of experience within regulatory affairs in the pharmaceutical industry or Biotech industry
  • Experience in nonclinical development, including designing pharmacology, pharmacokinetic, and toxicology studies
  • Ability to create and implement innovative regulatory strategies
  • Ability to understand and clearly communicate on topics of basic science
  • Good knowledge of the drug development lifecycle and regulatory requirements from clinical trials to marketing


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Regulatory Affairs DirectorWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Bicycle Therapeutics. The successful candidate will be responsible for developing and executing global regulatory CMC strategy and submissions for assigned programs or projects.The ideal candidate will have extensive...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Company OverviewBicycle Therapeutics is a pioneering pharmaceutical company pushing the boundaries of innovation in drug development. Our mission is to create life-changing therapies for underserved diseases.About the RoleWe are seeking a skilled Senior Associate, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be...


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

    We are seeking an experienced Regulatory Affairs Specialist to join our team at Vertex Ventures HC. In this role, you will play a critical part in ensuring the regulatory compliance of our cancer therapies.As a key member of our Regulatory Affairs team, you will be responsible for developing and executing global regulatory strategies for assigned programs or...


  • Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full time

    Job Title: Regulatory Affairs SpecialistEstimated Salary: $80,000 - $110,000 per annumAbout UsWe are a leading multinational pharmaceutical company based across global locations. Our mission is to accelerate access to affordable and innovative medicines.Job DescriptionThe successful candidate will be responsible for preparation and submission of UK MAA...


  • Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full time

    Job Overview: We are seeking an experienced Regulatory Affairs Manager to join our team in Cambridge, UK.About the Company:Dr. Reddy's Laboratories is a global pharmaceutical company with a presence in over 30 countries.We prioritize innovation, quality, and patient-centricity in everything we do.Key Responsibilities:Preparation and submission of MAA...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    About LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.Job Title: Global Clinical Program Manager for Biotech Regulatory AffairsWe are seeking a highly skilled Global Clinical Program Manager for our...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Senior Regulatory Associate PositionA highly rewarding opportunity awaits at Bicycle Therapeutics! We seek an experienced Senior Associate, Regulatory Affairs to spearhead our global regulatory strategy for various programs and projects. Join our dynamic team and make a meaningful impact in the world of pharmaceutical innovation.Role Highlights* Lead the...


  • 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 Dr. Reddy's Laboratories Full time

    Job Title: Regulatory Affairs SpecialistAbout Us:Dr. Reddy's Laboratories is a leading multinational pharmaceutical company based globally with over 24,000 employees.We accelerate access to affordable and innovative medicines for better health outcomes worldwide.Location: Dr. Reddy's (UK) Ltd, Cambridge (UK)Job Description:This role involves the preparation...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Gilead Sciences, Inc. is seeking a highly motivated and experienced Senior Associate, Regulatory Affairs CMC to join our team.Job Requirements:Minimum 3 years of experience in Regulatory Affairs CMC or relevant pharmaceutical industry experience.Knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director, Global TA Regulatory LiaisonsGilead Sciences, Inc. is a leading biotechnology company that discovers, develops, and commercializes innovative therapeutics to treat life-threatening diseases.Salary: $180,000 - $220,000 per yearJob Description:Act as the Regional Regulatory Lead on complex or multiple products, compounds, indications, or...


  • Cambridge, Cambridgeshire, United Kingdom Voisin Consulting SARL Full time

    About VCLSWe are a leading consulting firm offering expert regulatory services to the pharmaceutical and medical device sectors. Our team is dedicated to providing high-quality support to our clients, ensuring compliance with regulatory requirements.This 30-month programme is designed for recent graduates with an interest in medicines and a desire to build a...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Job SummaryWe are seeking an experienced Global Regulatory Affairs Expert to join our team at Gilead Sciences, Inc. This is a key leadership role responsible for defining and implementing regulatory strategies for multiple biopharmaceutical products across various therapeutic areas.About the RoleDevelop and execute global regulatory strategies for assigned...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job DescriptionCompany Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Our mission is to provide innovative solutions for businesses and professionals in the industry.SalaryThe estimated salary for this position...


  • 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 MoonLake Immunotherapeutics Full time

    Join MoonLake Immunotherapeutics as an Associate Director of Regulatory Affairs to spearhead innovative global regulatory strategies for sonelokimab lead indication(s).About the RoleCreate and execute cutting-edge regulatory plans to drive product development and approval, aligning with the company's global business strategy.As a key member of our team, you...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Job SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Lead regulatory activities across...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Full time

    About GileadGilead Sciences, Inc. is a global biopharmaceutical company dedicated to developing innovative treatments for life-threatening diseases. We're looking for talented individuals to join our team as Regulatory Affairs Manager.Job DescriptionThis role will act as the Regional Regulatory Lead on complex or multiple products, compounds, indications or...


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

    Job Title: Compliance and Regulatory Affairs DirectorAbout Bicycle Therapeutics:We are a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. Our team is passionate about improving the lives of patients and driving meaningful change in the industry.Job Summary:The Compliance and Regulatory Affairs...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    At Gilead Sciences, Inc., we're seeking a highly experienced Regulatory Affairs Manager to lead our Global Regulatory team in the development and implementation of regulatory strategies for our Therapeutic Area (TA) portfolio. This role will oversee the preparation and submission of regulatory documents, as well as ensure compliance with global...