Regulatory Affairs Manager

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About the Role

Regulatory Affairs Manager

Key Responsibilities

• Serve as the

  overall project lead and primary liaison

  with the sponsor.
• Provide strategic

  oversight of DSUR submissions

  , ensuring timely delivery and quality compliance.
• Manage

  communication and submissions with global Health Authorities

  (MOH, MFDS, TFDA, and others).

• Monitor and interpret regional regulatory updates

  to ensure continued compliance with evolving standards.
• Maintain a comprehensive

  regulatory intelligence repository

  for internal and client reference.
• Validate and confirm

  submission routes, formats, and requirements

  for each country or region.

Qualifications & Requirements

• Bachelor’s or Master’s degree in

  Pharmacy, Life Sciences, or Regulatory Affairs

  .

• 7+ years of experience

  in regulatory affairs, preferably within pharmaceuticals, biotech, or clinical research domains.
• Proven experience handling

  global regulatory submissions

  and coordinating with multiple health authorities.
• Strong understanding of

  ICH, FDA, EMA, and regional regulatory frameworks

  .
• Excellent communication, documentation, and stakeholder management skills.
• Ability to lead cross-functional teams and manage multiple projects simultaneously.