Head of Regulatory Affairs
Head of Regulatory Affairs
Industry: Pharmaceutical
Location: Midrand
Equity Requirement: EE
Large pharmaceutical manufacturing facility seeks to employ a Head of Regulatory Affairs. The following applies
Key Responsibilities
- Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
- Adopts a risk-based assessment for all regulatory submissions and formulates regulatory risk mitigation strategies, as applicable.
- Represent RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research & Development, where proactive input can then enhance operational efficiency,
- Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.
- Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Manages an off-site Regulatory Affairs support team.
Key Requirements
- B. Pharm Degree Registration with South African Pharmacy Council.
- A minimum of 8 years of pharmaceutical regulatory experience.
- A minimum of 5 years in people or team management is required.
- Demonstrated experience across the product development, commercialisation and dossier maintenance lifecycle.
(Full role profile available on application)
Apply to response@mvgrecruitment.co.za Subject: MP/HRA