Head Regulatory Affairs (Formulations)

Job Description

Candidate should be M.Pharmacy with 18-20 years of experience in Regulatory Affairs department from a reputed formulations manufacturing Industry. Regulatory Strategy and Compliance: Develop and implement regulatory strategies for product formulations to ensure compliance with all applicable regulations and guidelines. Stay updated with changes in regulatory environments and proactively assess their impact on product formulations. Regulatory Submissions: Oversee the preparation, review, and submission of regulatory documents, including INDs, NDAs, ANDAs, CTDs, and other regulatory filings. Ensure timely submissions and approvals by regulatory authorities such as FDA, EMA, and other global agencies. Cross-Functional Collaboration: Work closely with R&D to ensure that regulatory requirements are integrated into the product development process. Collaborate with quality assurance and manufacturing teams to ensure compliance during product formulation, testing, and production. Regulatory Guidance and Training: Provide regulatory guidance and training to internal teams to ensure understanding and compliance with regulatory requirements. Serve as the primary point of contact for regulatory matters related to formulations. Regulatory Intelligence: Monitor and analyze regulatory trends, changes, and advancements in the industry. Communicate relevant regulatory updates and implications to internal stakeholders. Documentation and Record Keeping: Maintain accurate and comprehensive records of regulatory submissions, correspondence, and approvals. Ensure that all regulatory documentation is up to date and readily accessible for audits and inspections. Regulatory Agency Interactions: Manage relationships and communications with regulatory agencies. Prepare for and lead regulatory agency meetings and inspections related to formulations.