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About the Organization:
PAREXEL is a leading global biopharmaceutical service provider that supports the biotech and pharmaceutical industries by aiding in the development of innovative drugs and treatments. They specialize in knowledge-based contract research, medical communications, and consulting services across therapeutic areas for pharmaceutical, biotechnology, and medical device sectors worldwide.

Position Details

Role: Manager, Regulatory Affairs
Location: Bengaluru, India
Industry Type: Pharma/Healthcare/Clinical Research
Experience Required: 10+ years of relevant experience in Clinical Trial Regulatory Submissions
Job ID: R0000024245
End Date to Apply: 30th December 2024

Key Responsibilities:

  1. Regulatory Submission Expertise:
    • Handle Clinical Trial Regulatory Submissions.
    • Act as Regulatory Lead for global trials, particularly focusing on the European market.
    • Manage the CTIS database and submit EU CTRs.
  2. Project Leadership:
    • Provide guidance to project team members and prioritize team workloads.
    • Facilitate issue resolution and decision-making within project guidelines.
    • Implement strategies for improved project efficiency and performance.
  3. Performance Management:
    • Manage performance reviews, salary actions, and bonus processes for team members.
    • Ensure compliance with PAREXEL policies and alignment with local staff regulations.
  4. Client & Quality Focus:
    • Produce high-quality work meeting client expectations.
    • Review team deliverables for quality assurance.
  5. Development & Networking:
    • Participate in self-development activities and maintain industry knowledge.
    • Engage with relevant scientific or technical associations.

Qualifications:

  • 10+ years of experience in managing clinical trial studies and regulatory submissions.
  • Expertise in European market regulations and CTIS database usage.
  • Strong leadership and conflict resolution skills.
  • Ability to produce quality deliverables under tight deadlines.

How to Apply:
Interested candidates can apply by visiting the PAREXEL careers page and searching for Job ID R0000024245.

Application Deadline: 30th December 2024

Application Link

Parexel Hiring Regulatory Affairs
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