Found Description
Regulatory Affairs Manager – Pharmaceuticals
We are seeking an experienced Regulatory Affairs Manager to drive regulatory strategy, launch readiness, compliance, and operational excellence across the Philippines while coordinating regulatory operations and selected cross-country initiatives across the ASEAN Cluster. This role is critical in safeguarding Bayer’s license to operate, enabling successful product launches, and ensuring ongoing compliance across the product lifecycle.
Responsibilities
- Lead regulatory strategy and execution for pipeline and marketed pharmaceutical products.
- Oversee submissions, registrations, renewals, variations, and lifecycle management activities.
- Build and maintain strong relationships with the Philippine FDA, health authorities, and key external stakeholders.
- Ensure compliance with regulatory requirements, audits, inspections, and internal quality systems.
- Monitor and assess ...