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Data Analyst Clinical Trials

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Data Analyst Clinical Trials

Job Title

Dhaka, Bangladesh

Job Location

Full-time

Job Type

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Job Overview:

The Regulatory Affairs Specialist will be responsible for managing regulatory processes, ensuring that products meet all applicable regulatory standards. This role includes coordinating with internal departments, preparing regulatory submissions, and liaising with health authorities. The individual will contribute significantly to regulatory strategies and ensure compliance with global and regional requirements.

Job Duties and Responsibilities:

  • Manage regulatory submissions and interactions with local and international regulatory agencies.
  • Ensure compliance with all applicable regulations, including regulatory requirements for product registrations.
  • Prepare and submit dossiers for new product registrations, renewals, variations, and other regulatory approvals.
  • Maintain regulatory documentation and databases.
  • Monitor changes in regulatory requirements and advise the relevant teams on the necessary actions.
  • Coordinate with cross-functional teams, including Quality Assurance, Research & Development, and Marketing, to ensure compliance across operations.
  • Support audits and inspections from regulatory agencies, ensuring all compliance documents are in place.
  • Act as a regulatory expert and provide guidance to the organization on regulatory strategies.

Job Requirements:

Education:

  • Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related field. A Master's degree will be a plus.

Experience:

  • Minimum of 3-5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
  • Experience in preparing and submitting regulatory documents (CTD, eCTD).

Skills/Competencies:

  • Strong knowledge of local and international regulatory requirements, including ICH, WHO, FDA, and EMA guidelines.
  • Excellent project management and organizational skills.
  • Ability to work under tight deadlines with minimal supervision.
  • Strong attention to detail and problem-solving skills.
  • Effective communication skills, both written and verbal.

Capabilities:

  • Ability to liaise effectively with internal teams and regulatory authorities.
  • Proficiency in using regulatory submission software and databases.
  • Capacity to handle multiple tasks and adapt to changes in regulatory environments.
  • Team player with leadership capabilities to guide junior regulatory staff.
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