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Senior Regulatory Affairs Pharmacist: OTC

2 months ago


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

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 ensuring compliance with regulatory requirements for our OTC medicines.

Key Responsibilities:
  • Manage work streams for- and report on the assigned portfolio of products
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • 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
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
  • Update and maintain databases, trackers and systems for all regulatory related activities
  • Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
  • Internal training and mentoring of peers when required
  • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
  • Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Support activities such as internal audits or regulatory agency inspections
Requirements:
  • Bachelor's Degree in Pharmacy. Diploma 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 for end-to-end regulatory activities
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards
  • Good Manufacturing Practices (GMP)
  • 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 and use POS24206 in the subject line.