Senior Manager - Drug Regulatory Affairs (Regulated Market)

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.