Manager Regulatory Affairs- South Africa markets at Macleods Pharma

Macleods Pharmaceuticals

Posted: 1 month ago
Openings: 10
Applicants: 0

Job Description

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 clear 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.