Regulatory Manager - Optimum Pharmaceuticals

Optimum Pharmaceuticals

  • Accra
  • Permanent
  • Full-time
  • 1 month ago
We are seeking a proactive and detail-oriented Regulatory Affairs Manager to join our pharmaceutical company based in Accra. This role is crucial to ensuring our products comply with all regulatory requirements and standards set by the Food and Drugs Authority (FDA) Ghana and other relevant bodies. The successful candidate will manage all aspects of regulatory submissions and approvals for new and existing products.Key Responsibilities:
  • Lead and manage the registration of new pharmaceutical products with the FDA Ghana.
  • Handle product re-registration processes and ensure timely renewals.
  • Maintain up-to-date knowledge of local and international regulatory requirements and ensure all company practices comply with them.
  • Liaise with regulatory authorities, including FDA Ghana, to facilitate communication and approvals.
  • Coordinate and prepare all necessary documentation for regulatory submissions, ensuring accuracy and completeness.
  • Monitor and implement regulatory changes and advise management on implications for product development and marketing.
  • Ensure that all products meet local and international safety, quality, and efficacy standards.
  • Work cross-functionally with departments such as Quality Assurance, R&D, and Marketing to support compliance initiatives.
  • Manage and complete all ad hoc regulatory tasks as required.
[ad]Requirements:
  • Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field. Advanced degree is a plus.
  • Minimum of 3–5 years of experience in regulatory affairs within the pharmaceutical industry.
  • Prior experience working with or within Ghana FDA is highly preferred.
  • Strong understanding of regulatory frameworks and drug registration processes in Ghana.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to manage multiple projects and meet tight deadlines.
  • Attention to detail and strong analytical skills.
Benefits:
  • Professional development opportunities
  • Supportive and collaborative work environment

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