Regulatory Manager - Optimum Pharmaceuticals
Optimum Pharmaceuticals
- Accra
- Permanent
- Full-time
- 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.
- 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.
- Professional development opportunities
- Supportive and collaborative work environment
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