Role & responsibilities

1.Regulatory Strategy: - Develop and implement regulatory strategies for successful product development, registration, and lifecycle management. - Stay abreast of global regulatory guidelines and adapt strategies to address the evolving requirements proactively.

2.Team Leadership: - Provide strong leadership and mentorship to a team of regulatory professionals. - Set explicit goals and expectations for team members and regularly assess their performance.

3.Regulatory Submissions: - Supervise the preparation, review, and timely submission of regulatory documents , MA applications, variations/supplements to global health authorities and South Africa authority , ensuring compliance with country-specific regulatory requirements.

4.Cross-Functional Collaboration: - Collaborate closely with R&D;, Manufacturing, and Quality Assurance teams to align regulatory strategies with overall business objectives, while maintaining a high level of compliance throughout the product lifecycle.

5.Provide regulatory guidance and support to other departments as needed.

📌 Manager Regulatory Affairs- South Africa markets at Macleods Pharma (Mumbai)
🏢 Macleods Pharmaceuticals
📍 Mumbai