Senior Regulatory Affairs Pharmacist (Permanent) - Midrand, Gauteng
Senior Regulatory Affairs Pharmacist (Permanent) - Midrand, Gauteng
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1 Vacancy
Job Description
POSITION: Permanent / Onsite
COMMENCEMENT: ASAP
PURPOSE OF POSITION:
Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries.
Qualifications Experience
- B. Pharm degree
- Knowledge of GMP; 1 2 years experience in regulatory affairs (SADC/EAC preferred)
- Knowledge of relevant medicine legislation and guidelines
- Ability to read regulatory guidelines assimilate and prepare accurate submissions
- Ability to justify exemptions where scientifically warranted
- Ability to work independently; follow instructions
- Excellent computer skills (Word Excel PowerPoint Outlook SAP)
Competencies:
- Business Competency: Customer orientation; ability to meet deadlines; goal & result orientation; problem solving; continuous improvement; assertiveness
- Strategic Competency: Strategic Orientation; cross-departmental thinking; sense of market and future trends; management of complexity
- Leadership Competency: Management by Objective; Coaching; Delegation; Planning & Organizing; Communication & negotiation; Teamwork; Empowering others
- Professional Competency: Expert know-how; passion for success; innovative; adaptability/flexibility; change fit
- Social and Intercultural Competency: Integrity; trustworthiness; quality & safety; values; conflict management; diversity; networking
Core Key Areas:
- Submission of new pharmaceutical products for registration
- Renewals of pharmaceutical products
- Maintenance of registrations
Activities:
- Evaluate dossier or variation documents and complete a gap analysis
- Compile and submit applications with any required data to the Health Authority
- Create a complete electronic copy of the application
- Attend to subsequent HA correspondence and address requests for additional information within deadlines
- Ensure product records/databases are updated in line with good documentation practices
- Review the impact of planned changes on registrations
- Review printed packaging for compliance with legislated requirements across markets
- Review marketing material for compliance with regulatory requirements
- Perform other tasks relevant to Regulatory Affairs as requested
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iSanqa is your trusted Level 2 BEE recruitment partner dedicated to continuous improvement in delivering exceptional service. Specializing in seamless placements for permanent staff temporary resources and efficient contract management and billing facilitation iSanqa Resourcing is powered by a team of professionals with an outstanding track record. With over 100 years of combined experience we are committed to evolving our practices to ensure ongoing excellence.
Employment Type
Full-time
