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    Head of Regulatory Affairs - Birmingham, United Kingdom - Gated Talent

    Gated Talent
    Gated Talent Birmingham, United Kingdom

    4 weeks ago

    Default job background
    Full time
    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?

    Have you worked on programs from preclinical stage to filing and launch? Fraser Dove International is partnering exclusively with an innovative biotechnology organisation specialising in oncology therapeutics. Operating globally, they are committed to enhancing treatment and clinical results for patients living with cancer.

    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; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed. Your objectives: 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. 3) Serving as the primary interface with the FDA,EMA and other international Health Authorities.

    What you will do: 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. Designs expedited approval pathways across multiple countries for each compound. Actively collaborates with medical affairs for marketed products and with safety for evaluating product side effects and risks during marketing phases.

    Offers expertise and actively engages in multidisciplinary/cross-functional program teams, closely cooperating with Program Leads managing one or more drug development programs. 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.

    Leads meetings with FDA, EMA, and national competent Health Authorities in the EU. Directs and contributes to reviewing responses to Health Authority queries in line with the global development strategy. Provides leadership and contributes to skill development, performance feedback, coaching, and mentoring, fostering a culture of learning and sharing best practices.

    Supervises interactions with CROs or other entities. What you will bring: These are the skills and experience you will need to succeed as the Head of Regulatory Affairs: Advanced degree in a scientific field (Ph. D., PharmD, or MD preferred) or equivalent relevant knowledge and experience. Accumulated over 8 years of experience in the pharmaceutical/biotechnology industry, with a focus on biologics.

    Demonstrated expertise in oncology, hematology, and immunology. 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. Held leadership positions in negotiations with Health Authorities across various regions.

    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. Established history of successful product development and market introduction (e.g., NDA/BLA/MAA submissions and approvals). 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).

    Demonstrated experience in engaging with the US FDA, including resolving issues through negotiation and influencing/lobbying directly and through external groups (e.g., trade associations). Direct management experience and a proven ability to form, lead, and manage cross-functional, cross-business teams; substantial experience in guiding regulatory strategy and teams. Adaptability to work within a matrix organization on a global scale and across diverse cultures and time zones.

    Availability for domestic and international travel as required for the role. What you will get: These are the perks and benefits that will complement your generous base salary: 20% bonus Stock options Benefits package Got what it takes?

    To apply for the Head of Regulatory Affairs, click the 'Apply' button below or contact the Executive Search Consultant – Katy Barber – on Please Note: This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.

    If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion. 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: Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry.

    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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