Regulatory Co Ordinator(Evening Shift)

23 hours ago

Karachi, Sindh, Pakistan Minerva Research Solutions Full time 1,200,000 - 3,600,000 per year
Company Overview:

Job Purpose:

The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies.

Key Responsibilities:
  • Working as a regulatory professional to ensure 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.
  • Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.
  • Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings.
  • Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner.
  • 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.
Qualifications:
  • 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.
Employment Type: Full-Time, On-site
Shift: Evening
Timings: 6 PM to 2 AM
Candidates with relevant background will be preferred.

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