Regulatory Affairs Manager - European Union - Planet Pharma

    Planet Pharma
    Planet Pharma European Union

    1 hari yang lalu

    Farmasi / Bioteknologi
    Deskripsi

    We are seeking a highly motivated Regulatory Affairs Associate/Manager to support a dynamic regulatory team on a portfolio of orphan pediatric medicinal products. This is a part-time, flexible role, ideal for someone with experience in EMA and UK regulatory submissions and lifecycle management.

    You will work across multiple products, supporting both centralised and national procedures, with exposure to orphan drug designations (ODD) and Pediatric Investigation Plans (PIPs).

    This is an exciting opportunity to join a supportive and collaborative team, with guidance and onboarding provided to help you quickly get up to speed.

    Key Responsibilities

    • Support preparation, review, and submission of EMA and UK regulatory dossiers
    • Assist with lifecycle management activities: variations, renewals, and post-approval updates
    • Contribute to ODD and PIP submissions and related documentation
    • Review labelling, patient-facing materials, and other regulatory documentation
    • Coordinate with cross-functional teams including Clinical, CMC, and PV
    • Track regulatory timelines and ensure compliance with SOPs, ICH, GCP, GMP, and national regulations
    • Adapt to a variable workload across multiple products

    What We're Looking For

    • Associate/Manager level with 3–10 years' experience in regulatory affairs
    • Experience with EMA submissions, centralised procedures, and UK MHRA submissions
    • Familiarity with orphan drugs, pediatric products, ODD, and PIPs preferred
    • Strong understanding of life cycle management (LCM) and post-marketing activities
    • Flexible, adaptable, and able to work independently while collaborating in a team
    • Excellent written and verbal communication skills
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Pekerjaan
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Regulatory affairs manager