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Senior Regulatory Affairs Pharmacist: OTC
2 months ago
Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements for our OTC medicines.
Key Responsibilities:- Manage work streams for- and report on the assigned portfolio of products
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- 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 the registration applications for submission to the regulatory authorities
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
- Update and maintain databases, trackers and systems for all regulatory related activities
- Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
- Internal training and mentoring of peers when required
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
- Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Support activities such as internal audits or regulatory agency inspections
- Bachelor's Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
- +-5 years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities
- 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
- A dynamic and supportive work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
To apply for this position, please send your MS Word format CV to and use POS24206 in the subject line.