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Clinical Trial Lifecycle Manager

2 weeks ago

Karachi, Sindh, Pakistan beBeeRegulatory Full time 7,000,000 - 8,500,000
Regulatory Affairs Coordinator (Evening Shift)

Transform the landscape of healthcare and research with our quality clinical services.

We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.

  • Data Operation
  • Recruitment Services
  • Regulatory

Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines & real-time solutions.

We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.

Job Purpose:

The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities.

Key Responsibilities:
  1. Ensure effective and efficient regulatory support for the company's products and activities.
  2. Develop and implement regulatory strategies that support the company's business objectives.
  3. Manage the preparation and submission of regulatory documents.
  4. Coordinate and manage regulatory inspections and audits.
  5. Keep abreast of changes in regulatory requirements and guidelines.
  6. Build and maintain positive relationships with regulatory authorities.
  7. Provide regulatory guidance and support to cross-functional teams.
  8. Collaborate with internal and external stakeholders to develop and implement regulatory policies.
Qualifications:
  • Bachelor's degree in a scientific discipline.
  • 01 years of experience in regulatory affairs.
  • In-depth knowledge of global regulatory requirements and guidelines.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Ability to work independently and manage multiple projects simultaneously.
Benefits:

Full-Time, On-site employment opportunity available for candidates with relevant background.