Global Head of Regulatory Affairs

1 week ago


UK, UK, United Kingdom Northreach Full time

Northreach have partnered with an exciting pharma company based in the UK that are recruiting for a Global Head of Regulatory Affairs to join their team. . The role will lead the regulatory team, interfacing with regulatory agencies like the MHRA, EMA, FDA, preparing and submitting regulatory documents, and managing risk. The role requires a deep understanding of global regulations, excellent leadership skills, experience working with CMO partners and extensive knowledge of drug development.


Key Responsibilities:


  • Develop and implement regulatory strategies while managing local regulatory partners and ensuring robust data management systems are in place.
  • Lead the creation and execution of comprehensive regulatory plans for global markets, ensuring adherence to both local and international regulations.
  • Oversee the preparation, submission, and ongoing management of regulatory documents (e.g., INDs, NDAs, MAAs) to health authorities such as the MHRA, FDA, EMA, and others.
  • Provide cross-functional leadership by coordinating with internal and external teams to ensure alignment with regulatory requirements.
  • Lead and develop the regulatory team, enhancing their knowledge, skills, and capabilities to effectively support the company's strategic objectives.
  • Serve as the primary liaison with regulatory agencies, managing communications and facilitating timely approvals.
  • Monitor global regulatory developments to ensure continuous compliance of products throughout their lifecycle.
  • Identify potential regulatory risks and develop effective mitigation strategies.
  • Lead training and mentorship initiatives within the regulatory affairs team, fostering regulatory expertise and growth within the organization.


Experience

  • Extensive background in regulatory affairs within the pharmaceutical, biotech, or medical device industries, with experience in global markets such as the US, EU, and Rest of World (ROW).
  • Comprehensive knowledge of regulatory requirements and guidelines from agencies like the FDA, EMA, and others.
  • Proven experience in leading small teams across multiple countries and time zones.
  • Strong expertise in GxP (Good Practice) standards.


If you are interested in hearing more, please apply with an up to date copy of your CV and I will be in touch.


All the best,

Taylor



  • UK, UK, United Kingdom Essential Pharma Full time

    Essential Pharma are looking for a Global Head of Regulatory Affairs. You will be responsible for leading a small team, developing and implementing regulatory strategies, interfacing with our partners and regulatory agencies. We are looking for deep GxP knowledge, an excellent leader and relationship builder. Apply Today!What You Will DoDevelop and implement...


  • UK, UK, United Kingdom EPM Scientific Full time

    Director Global Regulatory AffairsABOUT THE ROLEThe Director, Global Regulatory Affairs will be responsible for developing, implementing and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.Global Regulatory Affairs is expected to:• Provide high level...


  • London, UK, UK, United Kingdom Inflow Partnership Full time

    Our client is a leading European pharmaceutical company headquartered in London, England.They commercialise and distribute a portfolio of speciality brands and hospital products worldwide.They are currently recruiting for a Head of Regulatory Affairs, reporting to the CEO, who will manage a team of 2 people.The core duties of the position include:Developing...


  • UK, UK, United Kingdom EPM Scientific Full time

    ABOUT THE ROLE The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.DESCRIPTION OF THE ROLE• Provide high level strategic and operational regulatory direction and...


  • UK, UK, 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...


  • UK, UK, United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer 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 training. An excellent opportunity to start and establish your career in...


  • UK, UK, United Kingdom Walker Cole International Full time

    Walker Cole International is searching for an Senior Regulatory Affairs Manager to join an established global pharmaceutical business on a permanent basis. The organisation are an innovative business with a broad portfolio of products in both the generics and specialty branded product areas. The company offer a competitive salary and flexible working policy,...


  • UK, UK, United Kingdom VRS Regulatory Full time

    An R&D focussed global PPP company is looking for a Principal E-Fate Scientist to join their in-house Regulatory Science team.Become the e-fate expert / go to personOwn the e-fate dossier sectionSee projects from start to finishProduct are registered by in-house reg science teamLots of interaction with authorities / direct feedbackSolve unique challenges...


  • UK, UK, United Kingdom Cure Talent Full time

    Cure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring...


  • UK, UK, United Kingdom Actalent Full time

    Regulatory Affairs Manager (UK & Ireland)As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance (LPPV)...


  • UK, UK, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...


  • UK, UK, United Kingdom Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....


  • UK, UK, United Kingdom Bloom Careers Full time

    My client is a leading cosmetics manufacturer, working with the biggest names in the industry.As a result of their continued growth and success, the opportunity to recruit a Regulatory Affairs Manager has arisen to manage product compliance and product safety assessments. The successful candidate will have a background in chemistry, cosmetic science, or a...


  • UK, UK, United Kingdom AstraZeneca Full time

    Location – Remote, UKOutside IR35Duration – 12 monthsMake a meaningful difference at AstraZeneca!Bring out the best in each other, and yourself, by working together as one.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect,...


  • UK, UK, United Kingdom VRS Regulatory Full time

    An opportunity to join the Chemical Regulatory science team at an R&D focussed global PPP company. We are looking for an aquatic ecotoxicology risk assessor; this is a junior/mid-level position working alongside very experienced regulatory ecotoxicology professionals.The role involves:Developing dataRisk assessmentsProducing the ecotoxicology section of...


  • UK, UK, United Kingdom Barrington James Full time

    Excited to announce that Barrington James are partnered with a global Diagnostics company, who are looking to grow their team. They are looking for a long term engagement with a Freelance Global Regulatory Lead to assist on their upcoming projects:The details of the contract:5 days12 monthsFully remoteYou will be responsible for:Supporting R&D from...


  • UK, UK, United Kingdom Meet Full time

    Our client is a prominent organization dedicated to advancing innovative healthcare solutions. With a strong emphasis on regulatory excellence, they are committed to delivering safe and effective medicinal products globally.The Regulatory Affairs Manager will be responsible for managing the regulatory lifecycle of OTC and Consumer products, from initial...


  • UK, UK, United Kingdom Mars Full time

    We have an opportunity for a Senior Scientific and Regulatory Affairs - UK/IRL Market Lead (known internally as - Program Manager SRA (Science & Regulatory Affairs) UK/IRL) to join us at Mars. You will lead a variety of regional regulatory activities related to raw materials, finished products, labelling, claims, packaging and supporting UK/IRL. In this...


  • UK, UK, United Kingdom Centrik Global Consulting Full time

    Company DescriptionCentrik Global Consulting is a global consulting firm headquartered in London, UK, focused on providing comprehensive services to organizations in a rapidly changing landscape of risk and connectivity. With a global reach and clients across all continents, our services include Risk Monitoring, Risk Management Consulting, Foreign and...


  • UK, UK, United Kingdom SUN PHARMA Full time

    Overall Job Purpose:The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s...