Director of Regulatory Affairs - European Union - Apsida Life Science

    Apsida Life Science
    Apsida Life Science European Union

    2 hari yang lalu

    Farmasi / Bioteknologi
    Deskripsi

    Regulatory Director (Strategic Lead & MAA Specialist)

    Location: [European Union - Remote]

    Duration: 3 – 6 months (possibility of extension)

    Company Overview

    Apsida Life Science is currently partnering with a premium life science consultancy that specializes in fostering growth for pharmaceutical, biotech, and MedTech companies. They provide a holistic, cross-functional suite of services designed to navigate products through their entire lifecycle—from early-stage research and development to commercialization and post-market maintenance.

    Responsibilities:

    Strategic Advisory & Client Leadership:

    • Act as the Subject Matter Expert (SME) for clients, providing high-level strategic guidance on global and local regulatory pathways.
    • Translate complex regulatory requirements into actionable business strategies for C-suite stakeholders.
    • Lead Regulatory Intelligence efforts to anticipate shifts in the legislative landscape that could impact client portfolios.

    MAA Filing & Lifecycle Management:

    • Oversee the end-to-end preparation, management, and submission of Marketing Authorization Applications (MAA).
    • Manage post-approval maintenance, including variations, renewals, and line extensions.
    • Ensure all technical documentation (CTD/eCTD) meets the highest standards of quality and compliance for health authority review.

    Health Authority & Stakeholder Liaison:

    • Lead direct negotiations and communications with major regulatory bodies (e.g., EMA, FDA).
    • Represent the company and its clients during scientific advice meetings and oral explanations.
    • Manage the use of Power of Attorney (PoA) to act on behalf of the Marketing Authorization Holder (MAH).

    Operational Excellence:

    • Provide expert oversight on Blue Box requirements, labelling, artwork development, and linguistic reviews.
    • Support pricing and market access strategies from a regulatory perspective.
    • Allocate and manage resources effectively to ensure project milestones are met within defined hour caps and budgets

    Qualifications:

    • Education: Minimum of a Bachelor's degree in Life Sciences, Pharmacy, or a related field (Advanced degree preferred).
    • Experience: 10+ years in Regulatory Affairs, with a proven track record of successful MAA filings.
    • Strategic Mindset: Demonstrated ability to advise clients at a partner/strategic level rather than just a tactical level.
    • Compliance Knowledge: Expert-level understanding of EU/Global regulations.

    If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

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    Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

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