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Clinical Trials Regulatory Specialist

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Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Regulatory Manager Job Description

As a Regulatory Manager, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the success of our clinical trials. Your expertise in regulatory submissions and experience in managing clinical trial studies will be invaluable to our team.

  • Key Responsibilities:
  • Manage clinical trial studies and serve as a Regulatory Lead for global trials, with specific exposure to the European market.
  • Develop and implement strategies to achieve productivity, quality, and project goals and objectives.
  • Ensure Parexel policies and procedures are communicated to line personnel in accordance with local country regulations.
  • Provide technical and business consulting services in areas with clear policy or precedent.

Required Skills and Qualifications:

  • Over 10 years of relevant experience in Clinical Trial Regulatory Submissions.
  • Proven track record in managing clinical trial studies and serving as a Regulatory Lead for global trials, with specific exposure to the European market.
  • Expertise in handling the CTIS database and submitting under EU CTR is highly desirable.
  • Prioritizes personal workload and may prioritize the project teams workload to achieve project scope and objectives.
  • Seizes opportunities to enhance project efficiency, results, or team performance and proactively takes action.

Benefits:

  • Delivers quality work that meets client expectations and reviews colleagues work for content and quality to ensure client and Parexel standards are met.
  • Actively manages performance, including typical HR activities for direct reports (e.g., performance reviews, salary actions, bonuses, scorecards).

Others:

  • Maintains membership in relevant industry and/or scientific/technical associations to stay current in the industry.
  • Defines self-development activities to stay current in the industry.
  • Our commitment to improving health worldwide unites us, driving our dedication to deliver impactful and meaningful results.