Regulatory Affairs Director

3 weeks ago

Kimberley, Northern Cape, South Africa Unique Personnel Ltd Full time
Job Title: Regulatory Affairs Director - Pharmaceutical Industry

About the Role:
We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Unique Personnel Ltd. As a key member of our organization, you will be responsible for ensuring compliance with regulatory standards and guidelines in the pharmaceutical industry.

About You:
To be successful in this role, you will need to have a strong background in Regulatory Affairs, preferably in human medicines. A Bachelors degree in Pharmacy or Diploma in Pharmacy, along with registration with the South African Pharmacy Council, is essential. Additionally, you should have a minimum of 5 years experience in Regulatory Affairs, with sound project management capabilities and proven ability to deliver to quality, time, and cost standards.

About the Job:
This is an exciting opportunity to work as part of a dynamic team, providing superior Regulatory services to relevant departments within our company and external partners and Principals. Your primary responsibilities will include managing work streams, reporting on assigned groups of portfolios, and assisting with internal and external product queries. You will also be required to establish regulatory priorities, allocate resources and workloads, review regulatory agency submissions, coordinate new product applications, develop regulatory strategies, conduct dossier due diligence, and ensure maintenance and/or update of existing registrations.

Key Responsibilities:
  • Manage work streams for- and report on the assigned group of portfolios
  • Assisting with internal product queries from relevant departments
  • Assisting with 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
  • Co-ordinate and submit new product applications in South Africa and other applicable territories
  • 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
  • Work in collaboration with internal and external stakeholders to assess regulators' submissions requirements
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry

About the Company:
Unique Personnel Ltd is a leading provider of innovative solutions in the pharmaceutical industry. We offer competitive salaries, excellent benefits, and opportunities for professional growth and development. Our company values responsibility, excellence, collaboration, and customer relationships.

Salary: R1,200,000 - R1,500,000 per annum

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