Senior Director, Regulatory Affairs

2 months ago

Oxford, Oxfordshire, United Kingdom Cpl Full time

Job Title: Senior Director, Regulatory Affairs

Location: Oxfordshire, United Kingdom

Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)

Job Type: Full time, permanent position

Working for one of the industry's most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory knowledge to an early-stage development programs, with global focus.

In this role as a Senior Director, Regulatory Affairs you will manage worldwide interactions and negotiations with regulatory agencies and partners in support of radiopharmaceutical development activities. It is essential you have experience with FDA and therapeutic oncology trials. You will be a key member of project teams and responsible for developing regulatory strategy across the company. You will be responsible for ensuring the regulatory strategy is aligned with health authority requirements and regulatory submissions are on time and of high quality.

Job responsibilities:

· Working as a SME for the global regions responsible for all interactions with health authorities including driving global strategies for developing assets.

· Leading program teams in preparing regulatory submissions including briefing documents, IND and CTA filings.

· Execute clinical trial applications for assigned programs and provide leadership for team members responsible.

· Responsible for all areas of drug development including initial CTAs global, IND, NDA, BLAs, PIPS, ODD, IMPD, and Initial MAAs.

· Overseeing preparation of responses to all regulatory authority queries.

· Managing critical clinical regulatory timelines, working with team members to resolve issues related to clinical development and ongoing clinical trials, and working in partnership with the CMC team.

· Serving as the primary regulatory representative at internal meetings as well as at meetings with regulatory agencies for all clinical related issues

· Developing and maintaining detailed knowledge of global regulatory environment relevant for oncology therapeutics including accelerated review programs, and communicating changing regulatory agency requirements.

· Collaborating with external consultants, clinicians, CROs to provide regulatory guidance

· Evaluating regulatory program risks and establish mitigation strategies to optimise clinical development.

· Partnering with CMC, Non-Clinical, and Clinical Development organizations to innovate strategies to accelerate submission timeline

· Escalating issues to Senior Management that affect regulatory compliance.

· Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.

Job requirements:

· Advanced degree in a scientific discipline.

· A minimum of 15 years of regulatory experience with a focus on Radiopharmaceuticals supporting products through clinical development.

· Ideally a background in Oncology or extensive experience working in this therapeutic area.

· Experience of managing and developing staff members desirable.

· Proven track record of supporting Global Clinical Trial Applications through approval and study start up.

· Knowledge of both EMA and FDA regulations is required. Experience in filing regulatory submissions required.

· Experience directly writing submission documents is preferred

· Strong coaching, facilitation, and organizational skills, team player.

· Ability to negotiate and concisely express clear positions to stakeholders at all levels.

· Experience of directly working with national regulatory agencies and leading agency meetings face to face.

This is a great opportunity for a science-minded individual to work at the heart of innovation on a developing Radiopharmaceuticals and Oncology portfolio. You will take the lead and work with senior board members across the globe to define regulatory / business strategy.

If you are interested in this role or would like more details please email your CV to

Please note you MUST hold he FULL RIGHT TO WORK IN THE UK as this employee cannot offer sponsorship.

  • Director of Regulatory Affairs

    2 months ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Job Title: Director of Regulatory Affairs (CMC)Location: Oxfordshire, United Kingdom Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)Job Type: Full time, permanent positionWorking for one of the industry's most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory...

  • Regulatory Affairs Director

    6 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    **About SciPro**We are a leading provider of innovative medical solutions, specializing in AI-powered imaging biomarkers. As an exclusive partner of Brainomix, we are committed to delivering high-quality products that meet the highest regulatory standards.**Job Summary**We are seeking a highly experienced Senior Quality Assurance Manager to join our team. As...

  • Senior Manager, Regulatory Affairs Medical Devices

    3 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    Job Title: Senior Manager, Regulatory Affairs Medical DevicesJob Summary:We are seeking a highly experienced Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function for our medical devices.Key Responsibilities:Oversee the...

  • Senior Manager, Regulatory Affairs Medical Devices

    3 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    Job Title: Senior Manager, Regulatory Affairs Medical DevicesJob Summary:We are seeking a highly experienced Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function for our medical devices.Key Responsibilities:Oversee the...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Senior Regulatory Affairs Specialist – Medical Devices & IVD'sOxfordshire, UK – Office based Up to £60,000 + benefits This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home...

  • Regulatory Affairs Manager

    4 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Regulatory Affairs Manager

    6 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Regulatory Affairs Specialist

    23 hours ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job OpportunityCure Talent is excited to partner with a leading Medical Devices Manufacturer to fill a key role in their Regulatory Affairs team.Job SummaryWe are seeking an experienced Regulatory Affairs professional to support global product registrations, maintain design dossiers, and ensure compliance with international regulatory requirements.Key...

  • Regulatory Affairs Specialist

    20 hours ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job OpportunityCure Talent is excited to partner with a leading Medical Devices Manufacturer to fill a key role in their Regulatory Affairs team.Job SummaryWe are seeking an experienced Regulatory Affairs professional to support global product registrations, maintain design dossiers, and ensure compliance with international regulatory requirements.Key...

  • Regulatory Affairs Specialist

    1 day ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Cure Talent is excited 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.About the RoleThe new Regulatory Affairs Associate will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring...

  • Regulatory Affairs Specialist

    24 hours ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Cure Talent is excited 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.About the RoleThe new Regulatory Affairs Associate will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring...

  • Regulatory Affairs Specialist

    1 day ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job DescriptionCure 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.Key Responsibilities:Support global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory...

  • Regulatory Affairs Specialist

    23 hours ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job DescriptionCure 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.Key Responsibilities:Support global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory...

  • Regulatory Affairs Specialist

    4 hours ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job DescriptionCure 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.Key Responsibilities:Support global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory...

  • Regulatory Affairs Specialist

    1 hour ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job DescriptionCure 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.Key Responsibilities:Support global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory...

  • Regulatory Affairs Associate

    1 day ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job OpportunityCure Talent is excited to partner with a leading Medical Devices Manufacturer to fill an exciting role for a Regulatory Affairs Associate.Job SummaryWe are seeking an experienced regulatory professional to support global product registrations, maintain design dossiers, and ensure compliance with international regulatory requirements.Key...

  • Regulatory Affairs Associate

    1 day ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time

    Job OpportunityCure Talent is excited to partner with a leading Medical Devices Manufacturer to fill an exciting role for a Regulatory Affairs Associate.Job SummaryWe are seeking an experienced regulatory professional to support global product registrations, maintain design dossiers, and ensure compliance with international regulatory requirements.Key...

  • Regulatory Affairs Specialist

    6 days ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Job DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate post-market surveillance...

  • Associate Director, Government Relations

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Job SummaryThe Government Affairs Director will support the Corporate Affairs team by driving global government relations, while also contributing to the wider work of the team in corporate communications and internal communications. This role will focus on informing, uniting, and protecting the company's interests, aligning with Oxford Nanopore...

  • Senior Quality Assurance Manager

    5 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    **About SciPro**We are a leading provider of innovative solutions in the medical device industry, specializing in AI-powered imaging biomarkers. Our mission is to drive growth and excellence in our partnerships, and we are seeking a highly skilled Senior Quality Assurance Manager to join our team.**Job Summary**We are looking for a seasoned professional to...