Regulatory Affairs Expert
1 month ago
This role is available at Emporium Human Capital.
About the RoleThe successful candidate will be responsible for managing work streams for assigned products, assisting with internal and external product queries, establishing regulatory priorities, and reviewing submissions to ensure compliance with regulatory standards.
Key Responsibilities- Manage assigned product portfolios, ensuring timely and accurate submissions to regulatory authorities.
- Coordinate with internal and external stakeholders to assess submission requirements and ensure alignment with company values.
- Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
- Develop and implement regulatory strategies, policies, and procedures to enhance compliance.
- Support internal audits and regulatory agency inspections as needed.
- Bachelor's degree in Pharmacy or Diploma in Pharmacy, registration with the South African Pharmacy Council.
- 3-5 years' experience in Regulatory Affairs, preferably in human medicines.
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
- Sound project management capabilities, ability to prioritize and work under tight deadlines.
- IT skills, including CTD software builder and eCTD applications.
- Ability to network, liaise, and negotiate with others, set standards and objectives, and monitor progress.
- Complex problem-solving and decision-making skills, customer relationships, and development of people.
This position offers a competitive salary of R750,000 and opportunities for professional growth and development within Emporium Human Capital.
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