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    Associate Director/Director - Regulatory Affairs (Ema Expert)

    Medpace
    5+ years
    Not Disclosed
    London
    10 Nov. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director/Associate Director, Regulatory Affairs
    Company: Medpace
    Location: Office-Based (European Region)

    Job Summary
    Medpace, a global leader in clinical research for Biotech companies, is seeking a full-time Director/Associate Director of Regulatory Affairs to join our team. This strategic leadership role involves managing interactions with the European Medicines Agency (EMA) and shaping global drug development plans for our clients. Ideal candidates will have significant EMA experience, deep expertise in global drug development strategies, and a strong regulatory leadership background.

    Key Responsibilities

    • Develop and provide expert regulatory strategies to meet industry standards, ensuring compliance with guidelines, regulations, and agency precedent.
    • Advise project teams on regulatory strategy throughout the clinical development lifecycle.
    • Lead and collaborate on strategic initiatives such as gap analyses, regulatory authority meetings, and protocol development.
    • Stay updated on evolving regulatory requirements and proactively guide teams to address challenges.
    • Serve as a key liaison with national and regional regulatory agencies, including the EMA.
    • Provide regulatory expertise across multidisciplinary teams, including Clinical Operations, Pharmacovigilance, Biostatistics, and Medical Writing.

    Qualifications

    • Advanced Degree: MD, PhD in Life Sciences, or equivalent.
    • Experience: Minimum 5 years in regulatory drug development with demonstrated expertise in regulatory affairs across therapeutic areas.
    • EMA Expertise: Proven experience collaborating with the EMA, with prior involvement in EMA scientific committees preferred.
    • Strong understanding of global drug development processes and strategic planning.
    • Travel: Less than 10%.

    Why Medpace?

    • Flexible Work Environment: Tailored to support work-life balance.
    • Competitive Benefits: Comprehensive compensation packages, including PTO and employee wellness initiatives.
    • Career Advancement: Clear growth pathways with opportunities for professional development.
    • Employee-Centric Culture: Sponsored events, appreciation programs, and health-focused activities.

    Medpace Overview
    Medpace is a full-service clinical contract research organization (CRO) specializing in Phase I-IV clinical development for biotechnology, pharmaceutical, and medical device industries. With a mission to advance the global development of medical therapeutics, Medpace is known for its disciplined and scientific approach to clinical research.

    Headquartered in Cincinnati, Ohio, Medpace operates in over 40 countries, employing 5,000+ professionals across diverse therapeutic areas including oncology, cardiology, endocrinology, and CNS disorders.

    Awards & Recognition

    • Featured by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
    • Consistently honored with CRO Leadership Awards for quality, reliability, and capabilities by Life Science Leader magazine.

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