Executive - Regulatory Affairs

Role & Responsibilities

• Prepare and compile regulatory dossiers for drug registration submissions
• Liaise with regional and global regulatory teams to obtain supporting documentation
• Support DCGI and Health Authority submissions including PMS and Phase IV studies
• Coordinate and review clinical study reports, stability protocols and non-clinical reports
• Maintain regulatory dossiers, approvals and submission archives
• Support lifecycle management activities for registered pharmaceutical products
• Coordinate with regulatory consultants for effective submissions
• Manage regulatory trackers and documentation for tenders
• Ensure compliance with Indian regulatory requirements

Qualification

• Bachelor’s or Master’s degree in Pharmacy / Life Sciences / Related discipline

Experience

• Prior experience in Regulatory Affairs within pharmaceutical or healthcare industry
• Hands-on exposure to DCGI submissions preferred

Skills

• Strong knowledge of Indian regulatory framework
• Drug registration and lifecycle management expertise
• Excellent documentation and coordination skills
• Strong analytical and communication abilities
• High attention to detail and compliance orientation

About the Company

Johnson & Johnson is a global healthcare leader committed to advancing patient care through innovative medicines, medical devices and regulatory excellence.