Regulatory Affairs Pharmacist – Senior
- Johannesburg, Gauteng
- Permanent
- Full-time
- Bachelors in Pharmacy and SAPC registration
- MSc, MBA or PhD is an added advantage
- 8-10 years experience in regulatory affairs in human medicine is required
- Experience in registration of products and regulatory knowledge on South Africa, Botswana and Namibia market guidelines.
- Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
- Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.
- Regional Regulatory experience including knowledge of NDA, multisource product applications, and product lifecycle management processes.
- Demonstrate experience of effective delivery in a complex matrix environment.
- Knowledge of Regional Regulatory environment
- Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
- Knowledge of drug development, regulations and guidelines
- Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills
- Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
- Knowledge and understanding of quality systems, processes, audit and inspection
- Responsible for the regulatory management of South Africa and some Southern Africa markets like Botswana and Namibia for an allocated part of CLIENT's generic portfolio of products. Future markets and portfolio of products could be included as well as regulatory harmonisation occurs.
- Provide oversight for assigned countries for the portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions.
- Ensure regulatory input is communicated to the regional and local Commercial, Supply Chain and Quality teams for promoted and development products and the implementation of special projects.
- Ensure and supervise that regulatory documentation meets relevant regulatory requirements.
- Apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
- Ensure business continuity between Global Regulatory Strategists, Country Regulatory staff and distributors supporting regulatory activities on behalf of CLIENT