Senior Regulatory Affairs Pharmacist Complimentary Medicine Specialist

2 months ago


Midrand, Gauteng, South Africa Emporium Full time

Job Summary

We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. The successful candidate will be responsible for managing work streams for assigned portfolios of products, including internal and external product queries, and establishing regulatory priorities and allocating resources and workloads.

Key Responsibilities

  • Manage work streams for assigned portfolios of products, including internal and external product queries
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submissions to ensure timelines, accuracy, comprehensiveness, or 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
  • Work in collaboration 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
  • Proven ability to consistently deliver to quality, time, and cost standards
  • Good Manufacturing Practices (GMP)
  • Pharmaceutical production experience or exposure to supplement regulatory knowledge

Preferred Qualifications

  • Experience in use of CTD software builder and compilation of eCTD dossier applications
  • IT skills including Microsoft Office
  • Ability to prioritize and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • Active learning
  • Strategic thinking
  • Ability to cope with a high degree of complexity and change
  • Cross-functional skills: ability to network, liaise, and negotiate with others
  • Ability to set standards and objectives and monitor progress
  • Complex problem-solving and decision-making skills
  • Customer relationships
  • Development of people

How to Apply

Send your MS Word format CV to jobsemporium.co.za and use POS24204 in the subject line.



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