Regulatory Affairs Pharmacist Expert
1 week ago
We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for a motivated and experienced professional to take on a key role in ensuring the compliance and registration of pharmaceutical products.
About the RoleThis position involves managing work streams, reviewing regulatory agency submissions, and coordinating new product applications in South Africa and other applicable territories. You will be responsible for developing regulatory strategies, conducting dossier due diligence, and preparing registration applications for submission to regulatory authorities.
Key Responsibilities- Manage work streams for- and report on the assigned portfolio of products:
- Internal product queries from relevant departments
- External product queries from the SAHPRA, other MRAs and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
You will work closely with internal and external stakeholders to assess regulators' submissions requirements and ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations, and guidelines.
Requirements- Bachelors 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
The successful candidate will receive a competitive salary, benefits, and opportunities for career growth and development. They will also have the chance to work in a dynamic and supportive environment with a talented team of professionals.
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