- Ensure compliance with regulatory requirements, including FDA, OSD regulations, GMP guidelines, and other relevant standards.
- Conduct internal audits to identify areas of non-compliance and implement corrective actions.
- Develop and maintain policies, procedures, and training programs related to compliance management.
- Collaborate with cross-functional teams to ensure effective implementation of quality systems.
- Provide guidance on regulatory affairs matters and support product registration processes.
Desired Candidate Profile
- M.Pharma degree from a recognized institution (Any Specialization).
- Minimum 12-18 years of experience in pharmaceutical industry with expertise in Audit Compliance, Regulatory Compliance, Quality Assurance & Regulatory Affairs.
- Robust understanding of USFDA regulations and Good Manufacturing Practices (GMPs).
- Excellent communication skills for effective collaboration with stakeholders.