Senior Regulatory Affairs Pharmacist Complimentary Medicine Specialist

2 weeks ago


Midrand, Gauteng, South Africa Emporium Full time
Job Title: Senior Regulatory Affairs Pharmacist Complimentary Medicine

We are seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary Medicine to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our complementary medicine products.

Key Responsibilities:
  • Manage work streams for- and report on the assigned portfolio of products, including internal product queries and external product queries from regulatory authorities.
  • Establish regulatory priorities and allocate resources and workloads to ensure timely and accurate submissions.
  • Review regulatory agency submissions to ensure compliance with regulatory standards.
  • Develop regulatory strategies and implementation plans for new product applications, including dossier due diligence and submission preparation.
  • Collaborate with internal and external stakeholders to assess regulator's submissions requirements and ensure maintenance and/or update of existing registrations.
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.
  • Sound project management capabilities and ability to prioritize and work to tight deadlines.
  • Experience in use of CTD software builder and compilation of eCTD dossier applications.
  • IT skills including Microsoft Office and ability to maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
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 jobs@emporium.co.za and use POS24204 in the subject line.



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