DRA Manager (Drug Regulatory Affairs) Full Time

Company Description

Florencia Healthcare is a WHO-cGMP certified pharmaceutical manufacturer established in 2011 with a focus on improving human health. Recognized as one of India’s leading pharmaceutical manufacturers, the company is committed to high-quality, compliant production standards. Florencia Healthcare aims to build a strong reputation in the healthcare sector by combining scientific rigor with patient-centered values. Team members join a growing organization that values innovation, integrity, and regulatory excellence. The company offers opportunities to contribute to impactful healthcare solutions within a structured, quality-driven environment.

Role Description

This is a full-time, on-site DRA (Drug Regulatory Affairs) Manager role based in Noida. The DRA Manager will oversee the preparation, review, and submission of regulatory dossiers and product registration documents to national and international health authorities. Responsibilities include interpreting and implementing regulatory requirements, maintaining up-to-date knowledge of guidelines, and ensuring products comply with applicable laws and standards throughout their lifecycle. The role involves coordinating with cross-functional teams such as quality, manufacturing, R&D, and supply chain to support regulatory strategies and timely submissions. The DRA Manager will also monitor regulatory changes, manage responses to regulatory queries, maintain regulatory databases and documentation, and support audits and inspections.

Qualifications

• Strong expertise in Regulatory Affairs, including hands-on experience with regulatory submissions and product registrations.
• Proficiency in interpreting and applying Regulatory Compliance and Regulatory Requirements across relevant markets.
• Practical knowledge of Quality Systems in a WHO-cGMP or similar regulated pharmaceutical environment.
• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
• Experience in dossier compilation (e.g., CTD/eCTD/ACTD), variation filings, renewals, and post-approval change management.
• Ability to collaborate effectively with cross-functional teams and communicate clearly with internal and external stakeholders.
• Strong attention to detail, documentation skills, and ability to manage multiple projects and timelines.
• Prior experience in regulatory roles within the pharmaceutical industry, preferably with exposure to domestic and/or international markets.

Key Responsibilities:

✔ Regulatory dossier compilation, review & submissions

✔ Product registration and lifecycle management

✔ Coordination with regulatory authorities

✔ Ensuring compliance with national & international regulatory requirements

✔ Review, maintenance, and management of regulatory documentation

📌 Position: DRA Manager (Drug Regulatory Affairs)

📌 Experience: 5+ Years

📌 Qualification: B.Pharm / M.Pharm

📩 Apply Now:

Email: hrd@florenciahealthcare.com

Email: hr.florenciahealthcare@gmail.com

📞 Contact:

+91 8810226562

+91 9968996869