Senior Executive / Assistant Manager – Regulatory Administrative Services

About the role

The Senior Executive / Assistant Manager will support regulatory and product launch activities by coordinating documentation, change alerts and sample management across local and international markets.

Key responsibilities

• Plan and manage the Dossier Sample Submission Plan for regulatory countries according to the approved schedule.
• Facilitate the regulatory team in handling change alerts for product introductions and modifications, ensuring proper tracking.
• Coordinate code‑opening procedures for raw materials, packaging, semi‑finished and finished goods for new and renewal product development.
• Initiate pharmacovigilance (PV) forms linked to new product development and change‑management programmes.
• Support public relations activities for regulatory submissions, including arranging development samples, processing vendor payments and preparing dossier essentials.
• Contribute to departmental objectives and regulatory compliance initiatives.

Required profile

• Bachelor’s or Master’s degree.
• 4‑6 years of relevant experience in regulatory or pharmaceutical documentation.
• Proficiency with SAP S/4Hana module.

Required skills

• Good understanding of GMP processes and SOPs.
• Experience in change‑alert handling and public‑relations execution.
• Strong written and verbal communication abilities.
• Proficiency in Microsoft Word and Excel for routine tasks.