Senior Regulatory Affairs Pharmacist

Pharmacist ~ Regulatory
Johannesburg North-Gauteng

Our distinguished pharmaceutical client is currently seeking Senior Regulatory Affairs Pharmacists for their Complimentary Medicine (CAM) and Pain, Derma and Digestive (PDD) portfolios. In this role, you will collaborate with the Regulatory team to deliver exceptional regulatory services, ensuring strict adherence to legal and regulatory requirements set forth by relevant medicine Regulatory Authorities (as per country specifications), the Medicines and Related Substances Control Act, and the South African Pharmacy Council. Your primary responsibility will be to facilitate the prompt processing of regulatory applications.
    • Bachelor’s Degree or Diploma in Pharmacy  with the South African Pharmacy Council registration.
    • +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
    • Product development, commercialisation and maintenance lifecycle experience
    • Good Manufacturing Practices (GMP)
    • Pharmaceutical production experience or exposure to supplement regulatory knowledge.
Key Job outputs
    • Manage work streams and reporting for the assigned portfolio of products
    • Collaboration with internal and external stakeholders to assess the regulator’s submission requirements
    • Ensuring the maintenance and/or update of existing registrations following the relevant legislation, regulations, and guidelines for variations
    • Updating and maintaining databases, trackers, and systems for all regulatory-related activities.
    • Quality Management System(QMS): Complying with all requirements of QMS to ensure Good Regulatory Practices are maintained.
    • Maintaining current knowledge of relevant Acts, Regulations, and Guidelines on the pharmaceutical industry.
    • Internal training and mentoring of peers when required.
    • Establishing and maintaining effective relationships with RAs, internal and external stakeholders
    • Formulating or implementing regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced
    • Supporting activities such as internal audits or regulatory agency inspections
    • Ensuring alignment of personal and company values
If you are profient in CTD software builder and eCTD dossier compilation, coupled with expertise in systems and operations analysis, cost management, and strategic thinking, we encourage you to apply for the Senior Regulatory Affairs Pharmacist position. Your cross-functional skills, ability to set standards and objectives, and talent for monitoring progress will make you an invaluable candidate. Additionally, your aptitude for developing people will contribute to our continued success. Apply now to be part of this dynamic company and contribute to their regulatory excellence.