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    Senior European Regulatory Affairs Manager

    Vizen Life Sciences
    5+ years
    Not Disclosed
    India
    10 July 26, 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, 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

    Position: Senior European Regulatory Affairs Manager

    Location: Global Pharmaceutical Consultancy with European Affiliates in Czech Republic and the United Kingdom

    Are you a seasoned regulatory affairs professional seeking a high-impact role? Our leading global pharmaceutical consultancy, with established European operations in the Czech Republic and the United Kingdom, is looking for an experienced Senior European Regulatory Affairs Manager to drive our regulatory strategies and processes.

    About the Role:

    As the Senior European Regulatory Affairs Manager, you will play a pivotal role in managing the regulatory affairs for a diverse portfolio of products. Your primary responsibilities will include overseeing dossier management throughout the product lifecycle, from registration and renewal to variations and withdrawals. You will also lead a team of junior regulatory affairs professionals and collaborate closely with our European affiliates and EU authorities.

    Key Responsibilities:

    • Registration Project Management:

      • Lead the management of registration projects throughout the product lifecycle, including new registrations (CP, DCP, MRP), renewals, variations, and withdrawals.
      • Ensure compliance with the registration plan and oversee the execution of registration procedures.

    • Dossier Compilation and Coordination:

      • Compile and coordinate registration dossiers, focusing on Module I, II, IV, and V, and ensure they meet the requirements of CTD, eCTD, NTA, ACTD, or other formats as per legislative needs.
      • Collaborate with manufacturers on dossier content and formatting.

    • Collaboration with European Affiliates and Authorities:

      • Work closely with the Regulatory team in European affiliates to prepare and manage registration processes.
      • Serve as a liaison with EU authorities to ensure smooth regulatory interactions.

    • Process Participation and Management:

      • Participate in key company processes such as change control, risk assessment, and reporting.
      • Oversee the training and maintenance of regulatory software used within the team.

    • Internal and External Coordination:

      • Liaise with internal departments and external partners to facilitate regulatory processes and maintain compliance.

    What We’re Looking For:

    • Educational Background:

      • Degree in Pharmacy, Medicine, or Life Sciences.

    • Experience and Expertise:

      • Extensive knowledge of the marketing authorization process for medicinal products and dossier compilation.
      • At least 5 years of experience in regulatory affairs, particularly with dossier management and marketing authorization applications.

    • Skills and Qualifications:

      • Proficiency in English; additional languages are a plus.
      • Strong organizational and communication skills.
      • Flexibility, reliability, and enthusiasm for continuous learning.
      • Experience with electronic regulatory submission systems is preferred.

    • Preferred Qualifications:

      • Advanced degree (Master’s or PhD) in a relevant field.
      • Certification in Regulatory Affairs (RAC) is an advantage.

    Why Join Us?

    • Global Reach: Be part of a globally recognized consultancy with a robust network and reputation.
    • Leadership Opportunity: Lead and influence the future of our regulatory affairs initiatives.
    • Collaborative Environment: Work with top industry professionals and leaders in a dynamic and supportive setting.

    If you are ready to advance your regulatory affairs career and make a meaningful impact, we invite you to apply for the Senior European Regulatory Affairs Manager position. Join us and be at the forefront of regulatory excellence!

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