Senior Regulatory Affairs Executive

2 months ago

Newcastle upon Tyne, United Kingdom ProductLife Group Full time

Due to continued expansion we are currently seeking an additional Senior Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space.

This position requires a minimum of five years experience working in pharmaceutical regulatory affairs with knowledge of the drug development process, eCTD Dossier preparation, submissions management, and other regulatory functions. You will have the ability to work independently with minimal supervision as well as in a team and have an eye for detail with respect to documentation.

The position involves supporting the activities within the Regulatory areas of the company including drug safety and licensing of medicines.

You will have a degree in Life Sciences, Chemistry, Applied Biology or Pharmacy, excellent communication and negotiation skills, together with the ability to work independently.

Key Duties and Responsibilities

  • Lead the preparation and submission of regulatory submissions, including marketing authorization applications, variations, and lifecycle management activities, ensuring alignment with EMA and MHRA requirements.
  • Preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new licence applications, variations, PIQ submissions, responses to questions and renewals.
  • Develop and execute regulatory strategies tailored to the European and UK markets, ensuring timely product registration, approval, and post-market compliance.
  • Writing sections of the Module 3 of dossiers and Quality Overall Summaries
  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. Coordination and review technical documentation.
  • Collaborate closely with internal stakeholders, including Pharmacovigilance and Quality teams to align regulatory objectives and support business goals.
  • Collaborate closely with client teams and internal consultants to deliver comprehensive regulatory solutions that meet business objectives and regulatory standards.
  • Represent clients in interactions with European and UK regulatory agencies, including participation in regulatory meetings, responses to inquiries, and management of regulatory submissions.

Role Requirements

  • Graduate in a Science based subject. Minimum of 5 years experience in Regulatory affairs.
  • In-depth knowledge of European and UK regulatory requirements, procedures, and guidelines.
  • Excellent verbal and written communication skills with high level of attention to detail and accuracy of work.
  • Strong organisation skills and ability to cope with large volume of work across different areas of the company with changing deadlines.
  • Strategic mindset with a focus on delivering value-added regulatory solutions and fostering long-term client relationships.
  • Ability to work well both alone and as part of a team.


Behavioural Competence

  • Customer Focus: Manages their own activities to ensure they are focussed on delivering outstanding service to the end customer.
  • Teamwork: Can work well in a multi-disciplinary team and across teams to deliver requirements of role.
  • Flexibility: Able to adapt to meet the needs of the business at any point in time.
  • Problem-solving: Applies analytical thinking and creative problem-solving skills to overcome regulatory hurdles and deliver innovative solutions that drive client success.


Package Details

Competitive salary commensurate with experience, Annual performance related bonus, Contributory Pension, 25 days annual leave, East Midlands Office based but flexible working arrangements available.

  • Regulatory Affairs Officer

    5 days ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Quantumdx Group Full time

    QuantuMDx Group is seeking a highly skilled Regulatory Affairs Officer to join their team.The estimated salary for this position is £55,000 - £70,000 per year, depending on experience.Job OverviewThe Regulatory Affairs Officer will be responsible for ensuring that products meet regulatory requirements, including ISO 13485, ISO 14971, and IEC 62304...

  • Senior Director Regulatory Affairs- Rare Disease

    4 weeks ago

    Newcastle upon Tyne, United Kingdom CT19 Full time

    Senior Director Regulatory Affairs, Global Therapeutic Area HeadLocation: Candidate must have Right to Work in the UKRemote Working with International travel to HQ requiredAbout the company:We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of...

  • Regulatory Affairs Therapeutic Area Head

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    About the Company:CT19 is a pioneering European biotech organisation focused on developing cutting-edge therapeutics for rare diseases. With a strong track record of FDA success and a diverse pipeline of assets, we are committed to bringing innovative treatments to patients with unmet medical needs.Job Title: Senior Director Regulatory Affairs, Therapeutic...

  • Regulatory Affairs Director

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Planet Pharma Full time

    Planet Pharma is a leading pharmaceutical company with a strong presence in the UK, seeking an experienced Regulatory Affairs Director to lead our EU regulatory strategy.The successful candidate will have a deep understanding of EU regulatory requirements and a proven track record of leading successful engagements with the European Medicines Agency...

  • Solicitor for Regulatory Affairs

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Elevate Flexible Legal Resourcing Full time

    Job Title: Solicitor for Regulatory AffairsWe are seeking an experienced Solicitor/Lawyer to join our team as a Solicitor for Regulatory Affairs. The successful candidate will have a strong background in pharmaceutical regulations, intellectual property rights, and contract negotiation.About the RoleThis is an excellent opportunity to work with innovative...

  • Phd Graduate Ecotoxicologist

    4 days ago

    Newcastle upon Tyne, United Kingdom VRS Regulatory Full time

    An opportunity for a bright and ambitious PhD Graduate with a thesis related to ecotoxicology / environmental toxicology or the assessment of the effects of chemical in the environment. You will join the risk assessment team at a leading Regulatory Science Consultancy and take part in an exceptional training programme - an excellent career...

  • Regulatory Affairs Lead for Rare Diseases

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    About the RoleWe are seeking an experienced Senior Director to lead our regulatory affairs efforts in rare diseases. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to navigate complex regulatory landscapes.With a strong background in marketing applications, orphan drug...

  • Regulatory Affairs Expert

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BCL Legal Full time

    About the RoleBCL Legal is seeking a highly experienced Regulatory Affairs Expert to join our team in Newcastle. As a leading legal firm, we are committed to delivering exceptional service to our clients while maintaining the highest standards of compliance and ethics.In this critical role, you will be responsible for ensuring that our practices, records,...

  • Regulatory Affairs and Safety Strategy Senior

    7 months ago

    Kingston upon Hull, United Kingdom Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Regulatory Affairs Expert

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    Estimated salary: £120,000 - £180,000 per annum.We are seeking a highly skilled Senior Director Regulatory Affairs to join our team at CT19. As Global Therapeutic Area Head, you will play a pivotal role in ensuring regulatory approval across a diverse pipeline of assets.This is an exciting opportunity for a senior professional with experience in marketing...

  • Solicitor - Regulatory Affairs

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Sacco Mann Full time

    We are looking for a highly experienced Solicitor to join our legal team in Newcastle Upon Tyne, specializing in regulatory affairs and commercial contracts.As a key member of the team, you will assist the Legal Director in reviewing and managing contractual arrangements for various projects, ensuring compliance with relevant regulations and laws.A...

  • Senior Regulatory Affairs Specialist

    7 days ago

    Newcastle-under-Lyme, United Kingdom Page Group Full time

    Reporting to the RA Manager, the Senior RA Specialist will be leading the creation of registrations and submissions for new and existing products within the EU. **Client Details** My client is an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft...

  • Senior Director of Regulatory Affairs for Orphan Diseases

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    About Us:CT19 is a leading European biotech organisation dedicated to developing novel therapeutics for rare diseases. Our portfolio ranges from preclinical to approved products, with multiple new indications currently being explored. We are passionate about bringing innovative treatments to patients with unmet medical needs.Job Description:Senior Director...

  • Senior Director of Regulatory Excellence

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    Job Summary:We seek an exceptional Senior Director to lead our Regulatory Affairs team, navigating complex regulatory landscapes to drive business growth and deliver life-changing treatments. As Therapeutic Area Head, you will leverage your expertise in rare disease and orphan drug regulation to propel our pipeline forward.Key Responsibilities:Develop and...

  • Senior Director of Regulatory Strategy

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    Job DescriptionThis is an exciting opportunity to join CT19 as Senior Director Regulatory Affairs, Therapeutic Area Head. You will play a pivotal role in ensuring regulatory approval across our diverse pipeline of assets. Reporting directly to the Global Head of Regulatory, you will lead a small team of Regulatory professionals and make strategic decisions...

  • Senior Regulatory Affairs Professional

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    **Overview of CT19**We are a leading biotech organisation dedicated to developing innovative therapeutics for rare diseases.We have a strong track record of achieving FDA approvals and launching products in global markets.**Job Details:**Job Title: Senior Director Regulatory Affairs, Therapeutic Area HeadLocation: UK (remote working with international...

  • Regulatory Affairs Specialist

    24 hours ago

    Newcastle-under-Lyme, United Kingdom Brampton Recruitment Full time

    Our client is a global business that is specialists within its field, the company is a successful business that is currently undertaking an expansion, therefore, they are seeking an experienced Regulatory Affairs Specialist to join them. This role willbe responsible for ensuring regulatory products are registered in accordance with specific country's...

  • Regulatory Affairs Officer

    3 days ago

    Newcastle Upon Tyne, United Kingdom Jackson Hogg Full time

    Regulatory Affairs Officer Newcastle upon Tyne Competitive salary Jackson Hogg are thrilled to be partnered with a progressive MedTech company passionate about empowering the world to control disease and reduce suffering. based in Newcastle upon Tyne. Their latest development was a transformational point-of-care diagnostictool. A rapid, portable PCR...

  • Regulatory Affairs Director

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    **About CT19**We are a European biotech organisation developing novel therapeutics for a range of rare diseases.We have achieved FDA success with a few of our programs, which have now been launched in markets around the world. Our portfolio ranges from preclinical to approved products, with multiple new indications currently being explored.**Job...

  • Regulatory Affairs Director for Rare Disease Therapies

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

    Company Overview:CT19 is a European biotech organisation dedicated to developing novel therapeutics for rare diseases. With a strong portfolio ranging from preclinical to approved products, the company is expanding its pipeline with multiple new indications.About the Role:This exciting opportunity is for a Senior Director to lead Regulatory Affairs as...