Regulatory Affairs Pharmacist: Pain, Derma Expert

4 weeks ago


Midrand, Gauteng, South Africa Emporium Full time
Job Title: Senior Regulatory Affairs Pharmacist: Pain, Derma

Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for managing work streams and reporting on assigned portfolios of products.

Key Responsibilities:

  • Manage internal and external product queries from relevant departments and regulatory authorities.
  • Establish regulatory priorities and allocate resources and workloads.
  • Review regulatory agency submissions to ensure timelines, accuracy, and compliance with regulatory standards.
  • Coordinate 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 registration applications for submission to regulatory authorities.
  • Collaborate with internal and external stakeholders to assess regulator's submissions requirements.
  • Ensure the maintenance and/or update of existing registrations in accordance with relevant legislation, regulations, and guidelines.
  • Update and maintain databases, trackers, and systems for all regulatory related activities.

Requirements:

  • Bachelor's Degree 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 and ability to prioritize and work to tight deadlines.
  • Good Manufacturing Practices (GMP) and pharmaceutical production experience or exposure to supplement regulatory knowledge.

What We Offer:

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

To apply for this position, please send your MS Word format CV to the relevant email address and use the job reference number in the subject line.



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