The Regulatory Affairs Manager is responsible for leading regulatory strategy and ensuring compliance with global and regional regulatory requirements for pharmaceutical products throughout their lifecycle. This role plays a critical part in securing timely product approvals, supporting new product launches, maintaining existing product registrations, and ensuring adherence to evolving regulatory standards.The successful candidate will collaborate closely with Research & Development, Quality Assurance, Manufacturing, Supply Chain, Medical Affairs, Commercial, and external regulatory authorities to facilitate product registrations and lifecycle management activities. The role requires expertise in preparing and managing regulatory submissions, interpreting international regulatory guidelines, assessing regulatory risks, and ensuring compliance with applicable health authority requirements.As a key member of the regulatory leadership team, the Regulatory Affairs Manager will drive regulatory excellence, monitor changes in global regulations, support audits and inspections, and implement best practices that enable efficient market access

Responsibilities

• Develop and implement regulatory strategies to support product development, registration, and commercialization.
• Prepare, review, compile, and submit regulatory dossiers for new product registrations, renewals, variations, and post-approval changes.
• Manage regulatory submissions across domestic and international markets, ensuring timely approvals.
• Serve as the primary liaison with regulatory authorities and respond to agency queries, deficiency letters, and inspection observations.
• Ensure compliance with applicable regulations, including FDA, EMA, CDSCO, MHRA, WHO, ICH, and other global regulatory requirements.
• Collaborate with R&D, Quality Assurance, Manufacturing, Clinical, Medical Affairs, Supply Chain, and Commercial teams to support product lifecycle management.
• Review product labeling, packaging artwork, promotional materials, and technical documentation to ensure regulatory compliance.
• Monitor changes in global regulatory requirements and assess their impact on existing and pipeline products.
• Support regulatory inspections, audits, and compliance initiatives while ensuring readiness for health authority reviews.
• Maintain regulatory documentation, product licenses, registrations, and electronic regulatory information systems.
• Identify regulatory risks and develop mitigation strategies to ensure uninterrupted product supply and market access.
• Mentor and guide regulatory affairs professionals while driving continuous process improvement.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Biotechnology, Chemistry, or a related discipline.
• Experience: 8–15 Years
  Industry: Pharmaceuticals | Biotechnology | Medical Devices | Life Sciences | Healthcare

Preferred Experience

• Experience managing regulatory submissions across multiple international markets.
• Exposure to product lifecycle management, dossier maintenance, and regulatory intelligence.
• Experience supporting regulatory inspections, audits, and product approvals for pharmaceutical or biotechnology products.
• Knowledge of electronic submissions (eCTD), serialization, labeling regulations, and digital regulatory systems.

Core Competencies

• Regulatory Strategy
• Global Regulatory Affairs
• Product Registration
• CTD/eCTD Submission Management