Regulatory Affairs Specialist: Pain Management
2 days ago
Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium Human Capital. The successful candidate will be responsible for managing work streams, reviewing regulatory agency submissions, and coordinating the submission of new product applications in South Africa and other territories.
About Us: Emporium Human Capital is a leading human capital solutions provider that helps organizations find top talent. Our commitment to excellence and customer satisfaction has earned us a reputation as one of the most trusted recruitment agencies in the industry.
Responsibilities:
- Manage work streams for assigned portfolio of products
- Review regulatory agency submissions to ensure timelines, accuracy, comprehensiveness, and compliance with regulatory standards
- Coordinate the submission of new product applications in South Africa and other territories
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed
- Prepare registration applications for submission to regulatory authorities
- Collaborate with internal and external stakeholders to assess regulators' submission requirements
- Maintain existing registrations in accordance with relevant legislation, regulations, and guidelines
- Update and maintain databases, trackers, and systems for regulatory-related activities
- Ensure Good Regulatory Practices are maintained
- Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry
Requirements:
- Bachelor's Degree in Pharmacy or related field
- +/- 5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time, and cost standards
- Good Manufacturing Practices (GMP)
- Pharmaceutical production experience or exposure to supplement regulatory knowledge
Key Performance Indicators:
- Effective management of work streams
- Timely completion of regulatory submissions
- Compliance with regulatory standards
- Excellent communication and collaboration skills
- Maintenance of accurate and up-to-date records
Salary: R950 - R1,000,000 per annum
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