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    Regulatory Compliance - United Kingdom - Fraser Dove International

    Fraser Dove International
    Fraser Dove International United Kingdom

    1 week ago

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    Description
    Head of Regulatory Affairs
    Are you looking for a role to lead global regulatory filing strategy?
    Do you have recent experience of regulatory strategy for novel oncology modalities?

    Our client is seeking a dynamic leader to provide strategic input and leadership to project teams in support of developmental through to post-approval commitments.

    Discover more about our Head of Regulatory Affairs opportunity; As the Head of Regulatory Affairs, you will be measured against the following objectives:
    1) Leading a team of regulatory affairs associates, whilst becoming a core team member of cross-functional projects and executive leadership teams.
    2) Create and execute regulatory strategies on a global scale, which involves proactively identifying regulatory risks and exploring various options.
    As the Head of Regulatory Affairs, your duties and responsibilities will include:
    Lead a Regulatory Affairs team and offer guidance and mentorship to junior associates.
    Directs the formulation and implementation of comprehensive global regulatory strategy for the product portfolio.

    Ensures management is briefed on significant project issues, including any risk alterations, to convey a unified regulatory message to the SPC governance committee.

    Oversees peer review of crucial regulatory documents and submissions to maintain uniform quality across portfolio programs.

    Actively collaborates with medical affairs for marketed products and with safety for evaluating product side effects and risks during marketing phases.

    Provides overarching guidance on regulatory regulations.

    Monitors regulatory trends and guidelines, collaborating closely with the Chief Medical Officer to devise optimal regulatory strategies and support timelines effectively.

    Provides leadership and contributes to skill development, performance feedback, coaching, and mentoring, fostering a culture of learning and sharing best practices.

    These are the skills and experience you will need to succeed as the Head of

    Regulatory Affairs:
    Advanced degree in a scientific field (Ph.
    Accumulated over 8 years of experience in the pharmaceutical/biotechnology industry, with a focus on biologics.

    Proven track record in designing and overseeing regulatory aspects of clinical trials for at least 8 years; extensive experience in early-stage clinical development and global regulatory submissions and approvals preferred, with additional experience in late-phase trials being advantageous.

    Demonstrated leadership and achievement in all facets of regulatory affairs within a global/matrix environment in the pharmaceutical sector for a minimum of 2-5 years.

    Successful track record in managing global drug regulatory submissions.
    Proven capability to analyze and interpret efficacy and safety data.
    Familiarity with CMC regulatory guidelines across multiple countries.

    Thorough understanding of EMEA and FDA regulations and guidelines related to product development and clinical study conduct over 8-10 years; extensive experience in engaging with regulatory authorities (preferably in other countries).

    substantial experience in guiding regulatory strategy and teams.
    Availability for domestic and international travel as required for the role.

    20% bonus
    ~ Benefits package

    To apply for the Head of Regulatory Affairs, click the 'Apply' button below or contact the Executive Search Consultant – Katy Barber – on

    We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services.

    For more information on how we process your personal data, please view our Privacy Policy available on our website:


    Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

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