Regulatory Strategy and Compliance Lead

4 days ago


Karachi, Sindh, Pakistan Minerva Research Solutions Full time

Role Description:

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.

Responsibilities:

  • Work collaboratively with regulatory professionals to provide effective and efficient regulatory support for the company's products and activities.
  • Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.
  • Prepare and submit regulatory documents, including filings, registrations, and certifications.
  • Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective actions are taken in response to any findings.
  • Stay up-to-date on changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders.
  • Build and maintain positive relationships with regulatory authorities and other external stakeholders.
  • Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
  • Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.
  • Ensure timely and accurate reporting of regulatory activities and metrics.

Requirements:

  • Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
  • 1 year of experience in regulatory affairs, fresh graduates will also be preferred.
  • In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Ability to work independently and manage multiple projects simultaneously.
  • Strong attention to detail and accuracy.
  • Experience working in a fast-paced, deadline-driven environment.


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