Regulatory Compliance Specialist

19 hours ago

Karachi, Sindh, Pakistan beBee Careers Full time
Regulatory Affairs Coordinator

The Regulatory Affairs Coordinator plays a critical role in ensuring regulatory compliance of company products and activities. This involves working closely with regulatory professionals to prepare and submit regulatory documents, manage regulatory inspections, and develop and implement regulatory strategies that support business objectives.

Key Responsibilities:
  • Providing effective and efficient regulatory support for company products and activities.
  • Developing and implementing regulatory strategies that ensure compliance with relevant regulations and guidelines.
  • Managing the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.
  • Coordinating and managing regulatory inspections and audits, and ensuring corrective and preventive actions are taken in response to findings.
  • Staying up-to-date with changes in regulatory requirements and guidelines, and communicating these changes to stakeholders.
  • BUILDING strong 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 overall goals and objectives.
  • Ensuring timely and accurate reporting of regulatory activities and metrics.

Requirements:
  • Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
  • 01 years 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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