Job
Description
Role & responsibilities Senior Manager Drug Regulatory Affairs will lead regulatory strategy and operations for injectable pharmaceutical products targeted at regulated markets ( EU, Canada, Australia). This role is responsible for managing end-to-end regulatory submissions. Ensuring compliance with regional requirements, and coordinating with cross-functional teams including R&D, Quality, Manufacturing, and external partners to support product development and lifecycle management. Key Responsibilities: 1. Regulatory Strategy & Submissions: Develop and implement regulatory strategies for the injectable products for regulated markets. Oversee preparation, review, and submission of high-quality dossiers including ANDA, NDA, MAA, amendments, supplements, and annual reports. Ensure compliance with current regulations, guidance documents, and agency expectations. 2. Cross-Functional Coordination: Collaborate with formulation development, analytical, manufacturing, QA/QC, and project management teams to ensure timely and accurate compilation of regulatory documents. Provide regulatory inputs during development to ensure CMC data meet global submission requirements. 3. Communication with Regulatory Authorities: Act as a point of contact with regulatory agencies. Handle agency queries, deficiency letters, and pre-approval inspections (PAI) related documentation. Prepare teams for regulatory inspections; coordinate responses and corrective actions as required. 4. Lifecycle Management: Manage post-approval changes (CMC variations, labeling updates, product renewals). Maintain up-to-date regulatory documentation and ensure timely filing of amendments/supplements. 5. Team Leadership & Training: Mentor and supervise junior regulatory staff, providing guidance on dossier preparation and regulatory compliance. Foster a culture of continuous improvement and regulatory excellence. 6. Intelligence & Compliance: Monitor changes in regulatory guidelines and assess impact on current and future submissions. Ensure company-wide awareness of key regulatory updates and provide strategic advice accordingly. Preferred candidate profile 10+ years of relevant experience in regulatory affairs with a strong focus on injectable products. Proven track record of handling regulatory submissions and approvals in US, EU, and other regulated markets.
