A Regulatory Affairs Specialist in pharmaceutical manufacturing ensures that products-such as tablets, liquids, and injectables-comply with global regulations throughout their lifecycle. They prepare and submit regulatory filings (e.g., INDs, NDAs, eCTD dossiers), monitor evolving requirements (including FDA, EMA, and ICH Q8-Q11), and guide cross-functional teams (R&D, QA/QC, manufacturing) to maintain compliance while supporting product approvals and renewals.

• Knowledge of global regulatory guidelines
• Expertise in lifecycle management (IND/NDA to PSURs)
• Proficiency with eCTD/CTD systems (e.g., eCTD software, Veeva Vault)
• Skills in regulatory dossier compilation and submission
• Strong regulatory intelligence and project coordination skills
• Rigorous attention to detail and quality standards
• Ability to strategically plan and manage submissions
• Cross-functional collaboration with R&D, QA/QC, and manufacturing teams
• Agility in adapting to evolving regulations, including digital health trends
• Effective communication with regulatory agencies and internal stakeholders

• Under Graduation
• 1 year of experience