Regulatory Affairs Pharmacist
1 month ago
We are seeking an experienced Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our pharmaceutical compliance team, you will play a critical role in ensuring the registration and maintenance of our products in accordance with regulatory requirements.
About the RoleThis is an exciting opportunity for a skilled Regulatory Affairs Pharmacist to take on a challenging position that involves managing work streams, reporting on product portfolios, and coordinating submissions to regulatory authorities. The successful candidate will have experience in human medicines, including complementary medicines and medical devices, and a strong understanding of Good Manufacturing Practices (GMP) and pharmaceutical production.
Main Responsibilities- Manage work streams and report on assigned product portfolios, including internal and external queries from relevant departments and regulatory authorities
- Establish regulatory priorities, allocate resources, and workload, ensuring timely and accurate submission of materials to regulatory agencies
- Review and coordinate new product applications, develop regulatory strategies, and prepare dossier due diligence to address data gaps
- Prepare registration applications for submission to regulatory authorities, maintaining current knowledge of relevant Acts, Regulations, and Guidelines
- Maintain effective relationships with regulatory authorities, internal stakeholders, and peers, ensuring alignment with company values
To be successful in this role, you will require:
- 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
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle
- Sound project management capabilities, ability to prioritize and work to tight deadlines, and strategic thinking
- Good Manufacturing Practices (GMP), pharmaceutical production experience or exposure to supplement regulatory knowledge
- IT skills, including Microsoft Office, and CTD software builder experience for eCTD dossier applications
In return for your expertise and dedication, we offer a competitive salary package, including:
- A salary range of R900 000 - R1 000 000 per annum, depending on experience
- Ongoing professional development and training opportunities
- A collaborative and dynamic work environment
- The opportunity to work on challenging projects and contribute to the growth and success of our organization
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