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Senior Regulatory Affairs Pharmacist
3 weeks ago
Senior Regulatory Affairs Pharmacist Pharmacist ~ Regulatory
Johannesburg North-Gauteng
Qualifications/experience
- Bachelors 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
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