Manager - Regulatory Affairs (OSD) - South Africa Market
About the Job
Manager – Regulatory Affairs (OSD – South Africa)
🎓 Qualification: M.Pharm
🕒 Experience: 13 – 16 Years
🎯 Role Overview
Lead and manage Regulatory Affairs operations for the South Africa market, ensuring strategic alignment with global regulatory requirements.
✅ Key Responsibilities
✔ Lead regulatory strategy for SAHPRA submissions
✔ Oversee dossier compilation, variations, renewals & lifecycle management
✔ Handle complex authority interactions & deficiency responses
✔ Ensure alignment with FDA, EMA & international regulatory standards
✔ Mentor team members and manage submission timelines
✔ Drive regulatory compliance and process improvements
👤 Ideal Candidate
- Extensive experience in South Africa Regulatory Affairs – OSD
- Strong leadership exposure within Regulatory function
- Deep understanding of global regulatory guidelines (FDA, EMA)
- Strategic mindset with strong stakeholder management skills
About the Company
Overview
BIG PHARMA JOBS is India’s leading recruitment platform dedicated exclusively to the Pharmaceutical industry. Since 2010, we have been connecting top talent with leading pharma companies through our specialized recruitment services.
We operate under our parent company, BIG IDEAS HR Consulting Pvt. Ltd., a trusted name in the HR industry. Headquartered in Ahmedabad, we have expanded our footprint with branch offices in Pune, Bangalore, Indore, Noida, and more.
Over the past decade, we have proudly partnered with 1,000+ pharma companies and successfully placed over 25,000 candidates across various domains and levels.
To further strengthen our commitment to the pharma ecosystem, we have recently launched our own job portal – a dedicated platform designed to serve pharmaceutical professionals and companies alike. This portal aims to be a one-stop recruitment solution, simplifying the hiring process and job search experience in the pharma sector.
At BIG PHARMA JOBS, our vision is to create India’s most trusted and comprehensive job portal for the pharmaceutical industry – empowering careers and building organizations, one placement at a time.
Skills
Key Details
- Experience:
- 13+ Years
- Job Domain/Function:
- regul
- Job Type:
- Work From Office
- Employment Type:
- Full Time
- Number of position(s):
- 1
- Educational qualifications:
- M.Pharma