Key Responsibilities:

- Regulatory Submissions: Prepare and submit regulatory documents (e.g., INDs, NDAs, ANDAs, CTDs, etc.) to health authorities (FDA, EMA, etc.).
- Regulatory Compliance: Ensure compliance with all regulatory requirements for drug development, clinical trials, marketing, and post-market activities.
- Cross-Functional Collaboration: Work closely with R&D;, Quality Assurance, Marketing, and Manufacturing teams to ensure regulatory strategies align with business goals.
- Regulatory Strategy: Develop regulatory strategies for current product development, clinical trials, and lifecycle management.
- Regulatory Intelligence: Monitor regulatory changes, trends, and guidance documents to stay current with industry standards.
- Labeling and Documentation: Review and approve product labeling, packaging, and promotional materials for regulatory compliance.
- Risk Management: Assess and mitigate regulatory risks in the development and marketing of products.
- Agency Interactions: Communicate with regulatory agencies to resolve issues, respond to queries, and gain approvals.
- Technical Proficiency: Familiarity with regulatory software and document management systems.

📌 Senior Executive (India)
🏢 Metrochem API
📍 India