Global Regulatory Affairs Manager

4 days ago


Karachi, Sindh, Pakistan Minerva Research Solutions Full time

Our Mission:

At Minerva Research Solutions, we strive to transform the landscape of healthcare and research through our quality clinical services. Our mission is to deliver high-quality data and solutions that enable clients to speed up the lifecycle of novel therapies.

Job Summary:

The Regulatory Coordinator will work as a team member of regulatory professionals to ensure regulatory compliance of company products and activities. This includes preparing and submitting regulatory documents, managing regulatory inspections, and developing regulatory strategies.

Key Responsibilities:

  • Providing effective and efficient regulatory support for the company's products and activities.
  • Developing and implementing regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.
  • Preparing and submitting regulatory documents, including filings, registrations, and certifications.
  • Coordinating and managing regulatory inspections and audits, and ensuring appropriate corrective actions are taken in response to any findings.
  • Staying up-to-date on changes in regulatory requirements and guidelines, and communicating these changes to relevant stakeholders.
  • Maintaining positive relationships with regulatory authorities and other external stakeholders.
  • Providing regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
  • Collaborating with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.
  • Ensuring timely and accurate reporting of regulatory activities and metrics.


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