Job Description
1.Manage day-to-day Regulatory Affairs activities and submissions.
2.Handle new product registrations, renewals, variations, and post-approval changes.
3.Prepare and review regulatory dossiers and submission documents.
4.Ensure compliance with applicable regulatory guidelines and requirements.
5.Coordinate with R&D;, QA, QC, Production, and other departments.
6.Track submission timelines, commitments, and regulatory milestones.
7.Review regulatory guidelines and assess their impact on products.
8.Manage regulatory queries and responses to authorities.
9.Lead, mentor, and monitor the Regulatory Affairs team.
10.Maintain regulatory records, databases, and documentation.

Requirements

1.Bachelor’s/Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.




2.Minimum 5+ years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
3.Mandatory team handling/people management experience with the ability to lead and mentor regulatory professionals.
4.Solid knowledge of regulatory submissions, product life-cycle management, regulatory guidelines, and compliance requirements.
5.Strong communication, analytical, documentation, project management, and cross-functional coordination skills, with the ability to manage multiple projects and strict timelines.

Pay: ₹50,000.00 - ₹60,000.00 per month

Work Location: In person

📌 Assistant Manager (Selakui)
🏢 Rhydbrug Biotech
📍 Selakui