Key Responsibilities: 1. Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. 2. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. 3. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. 4. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. 5. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. 6. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. 7. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. 8. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. 9. Risk Management: Identify potential regulatory risks and develop mitigation strategies to address them proactively, while fostering a culture of compliance within the organization. 10. Training and Development: Provide training and guidance to internal stakeholders on regulatory requirements, processes, and best practices to enhance regulatory compliance awareness and capabilities. Qualifications: Bachelor's or Master's degree in a relevant scientific discipline (e.g., biology, pharmacy, chemistry) or regulatory affairs. 9-10 years of experience in regulatory affairs or quality assurance within the biopharmaceutical industry, with specific experience in biological products preferred (rDNA). Strong knowledge of regulatory requirements and guidelines for biological products, including CDSCO, FDA, EMA, and other global regulations. Experience in preparing and submitting regulatory documents and interacting with regulatory agencies. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously. Proven ability to collaborate cross-functionally and influence stakeholders at all levels of the organization
