About the position
Well established pharmacuetical business seeking to appoint Senior Regulatory Affairs Pharmacist.
SKILLS & QUALIFICATIONS:
- Bachelor’s degree in Pharmacy, registered with the South African Pharmacy Council
- MSc, MBA or PhD may be an advantage.
- Experience in regulatory affairs, preferably in human medicines - minimum 8 years of experience.
Key Knowledge and Skills 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
Please note that if you have not received a response within 14 days of submitting your application that your application was unsuccessful.
However, please keep a lookout on our website, [URL Removed] for available positions which may be inline with your career aspirations.
Desired Skills:
- regulatory affairs
- registration of products
- pharmaceutical
