Regulatory Affairs, Operations Executive

Key Responsibilities

• Prepare, review, organize, and maintain regulatory documents and records.
• Support the preparation and submission of regulatory applications, dossiers, and supporting documentation, as applicable.
• Monitor regulatory requirements, submission deadlines, renewals, and documentation updates.
• Maintain regulatory trackers and ensure records are accurate and readily accessible.
• Coordinate with internal departments and external stakeholders to obtain required regulatory information and documents.
• Assist with reviewing product documentation and ensuring alignment with applicable regulatory guidelines.
• Support compliance activities, document control, and preparation for regulatory inspections or audits.
• Track regulatory changes and communicate relevant updates to the concerned teams.
• Follow established procedures for document management, record keeping, and regulatory reporting.

Requirements & Tech Stack

• Proficiency in Microsoft Office, particularly Word and Excel.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, or a related discipline.
• Relevant experience in Regulatory Affairs, regulatory documentation, or regulatory compliance.
• Experience preparing, reviewing, and maintaining regulatory records and supporting documents.
• Strong documentation skills.
• Attention to detail.
• Understanding of applicable regulatory guidelines, submission procedures, and documentation requirements.
• Good organizational skills and the ability to manage multiple documentation tasks and deadlines.
• Strong written communication skills.
• Ability to coordinate with cross-functional teams.
• Location Preference: Delhi NCR region.