Senior Executive

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 new 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.