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    Manager, Regulatory Affairs

    Parexel
    10+ years
    Preferred by Comapny
    Bengaluru
    12 Nov. 25, 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: Clinical Trial Regulatory Lead

    Key Responsibilities:

    1. Clinical Trial Regulatory Submissions:

      • Oversee and manage regulatory submissions for clinical trial studies with over 10 years of experience in handling such submissions.
      • Provide leadership as the Regulatory Lead for Global Trials, especially with a focus on the European market.

    2. CTIS Database Expertise:

      • Demonstrate proficiency in handling the CTIS database and submitting EU Clinical Trial Regulation (EU CTR) submissions, an essential skill for managing European trial data.

    3. Project Guidance & Leadership:

      • Provide mentorship and guidance to project team members, ensuring regulatory aspects are handled efficiently and accurately.
      • Work within broad project guidelines, ensuring smooth execution and meeting client expectations.

    4. Issue and Conflict Resolution:

      • Take the lead in resolving issues and conflicts within the project team to ensure effective project delivery.

    5. Workload Management:

      • Prioritize own workload effectively and may also prioritize the workload of the project team to ensure that project scope and objectives are met on time.

    6. Project Efficiency Improvement:

      • Identify opportunities for project improvements, capitalizing on opportunities to enhance team performance, project results, and efficiency.
      • Take proactive actions to implement improvements.

    7. Leveraging Past Experience:

      • Utilize insights from previous projects or other client work to complete assigned tasks efficiently and to facilitate informed business decisions.

    8. Quality Assurance:

      • Ensure all work produced meets high-quality standards, aligns with client expectations, and is reviewed for content and quality.
      • Review colleagues' work to ensure the same quality and consistency is maintained across the team.

    9. Strategic Planning and Problem Solving:

      • Assess project challenges and develop strategies to meet productivity, quality, and project goals.
      • Ensure the successful completion of projects by addressing issues proactively.

    10. Performance Management:

      • Actively manage performance, including conducting performance reviews, salary actions, and monitoring key metrics like bonuses and scorecards for direct reports.

    11. Policy and Procedure Alignment:

      • Ensure PAREXEL policies and procedures are communicated effectively to staff in alignment with the local country regulations.

    12. Consulting Services:

      • Provide comprehensive technical and business consulting services, particularly where policy or precedentis well-established.

    13. Self-Development:

      • Define and engage in self-development activities, ensuring up-to-date knowledge of industry trends.
      • Maintain professional development through relevant industry and scientific/technical associations.

    Required Skills & Qualifications:

    • Experience: 10+ years of experience in clinical trial regulatory submissions, including managing global trials and strong exposure to the European market.
    • Technical Skills: Proficiency with the CTIS database and knowledge of EU CTR submissions.
    • Leadership: Ability to guide teams, manage workload, and mentor staff, ensuring alignment with project objectives and regulatory guidelines.
    • Quality Management: Proven ability to assess and improve project efficiency and quality.
    • Consulting: Ability to provide business and technical consulting services effectively within clear policy and regulatory frameworks.
    • Communication: Excellent communication skills to facilitate team collaboration and maintain client expectations.
    • Project Management: Strong project management capabilities, including issue resolution, strategy development, and performance management.

    Educational Requirements:

    • Degree: A degree in life sciences, pharmacy, or related field is required. Advanced qualifications or certifications in regulatory affairs would be an asset.

    This role is vital for ensuring successful clinical trial regulatory submissions while maintaining high standards of quality and efficiency. The Clinical Trial Regulatory Lead will contribute significantly to the successful management of global trials, especially in the European region, while leading teams and optimizing project outcomes.

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