Regulatory Affairs Pharmacist Lead
4 hours ago
We are seeking a highly skilled Regulatory Affairs Pharmacist Lead to join our team at Emporium Human Capital.
In this role, you will be responsible for managing work streams and reporting on assigned portfolios of products. You will establish regulatory priorities, allocate resources, and workloads, while ensuring compliance with regulatory standards.
Your key job outputs will include:
- Coordinating and submitting new product applications in South Africa and other applicable territories
- Developing regulatory strategies and implementation plans for the preparation and submission of new products
- Conducting dossier due diligence to ensure all data gaps are addressed
- Maintaining and/or updating existing registrations in accordance with relevant legislation, regulations, and guidelines
You will also be responsible for maintaining current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry, as well as establishing and maintaining effective relationships with Regulatory Authorities, internal, and external stakeholders.
To succeed in this role, you will need to have:
- 5+ years of 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 and proven ability to consistently deliver to quality, time, and cost standards
The ideal candidate will possess excellent communication and interpersonal skills, with the ability to prioritize and work to tight deadlines. You will also need to have a strong understanding of Good Manufacturing Practices (GMP) and Pharmaceutical production experience or exposure to supplement regulatory knowledge.
What We Offer
We offer a competitive salary of R900k - R1m per annum, depending on experience, as well as opportunities for professional growth and development.
If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please apply today
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