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Regulatory Affairs Specialist

2 months ago

Pretoria, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time
Key Responsibilities
  • Manage and report on a portfolio of products, ensuring timely and accurate regulatory submissions. Provide support for internal and external queries and establish regulatory priorities. Review submissions from regulatory agencies for compliance and accuracy.
  • Develop and implement regulatory strategies for new product applications, conducting dossier due diligence to address data gaps. Prepare and submit registration applications to regulatory authorities in South Africa and other territories.
  • Collaborate with internal and external stakeholders to assess and meet regulatory requirements. Maintain existing registrations and ensure compliance with relevant legislation, regulations, and guidelines.
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines in the pharmaceutical industry. Establish and maintain relationships with regulatory authorities and stakeholders.

MNA Recruitment (Pty) Ltd seeks a skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a Bachelor's degree in Pharmacy and registration with the South African Pharmacy Council, with at least 5 years of experience in Regulatory Affairs, preferably in human medicines.

Key qualifications include sound project management capabilities, proven ability to deliver to quality, time, and cost standards, and experience with CTD software builder and compilation of eCTD applications. The successful candidate will be able to prioritize and work to tight deadlines, possess systems and operations analysis skills, and demonstrate responsibility, excellence, and collaboration.

Applications may be submitted via this portal or via the vacancy link on www.mnarecruitment.com. Please note that if you do not receive feedback within 7 days, your application will be considered unsuccessful.