Graviti Pharmaceuticals - Regulatory Manager
Posted 2 weeks ago
Posted 2 weeks ago
Description:
Location: Hyderabad, India.
Experience: 10-12 Years.
Industry: Pharmaceuticals / Healthcare.
Employment Type: Full-time.
About the Company:
Focused on innovation and development, Graviti channels a significant share of its revenue into advanced research, driving the creation of next-generation therapies and high-impact pharmaceutical solutions.
As part of our global expansion, we are now entering the European market to deliver high-quality healthcare solutions worldwide.
Role Overview:
The role requires strong expertise in handling solid oral and sterile dosage forms and a deep understanding of European regulatory guidelines.
Key Responsibilities:
- Prepare, review, and submit dossiers (CTD/eCTD) in line with EMA and EU regulatory requirements.
- Handle post-approval regulatory activities, including variations, renewals, and lifecycle management.
- Coordinate with cross-functional teams R&D, QA/QC, Production, and Supply Chain to ensure compliance and timely submissions.
- Stay updated with evolving EU/EMA regulations and ensure company processes remain aligned.
- Coach and develop team members to strengthen their regulatory expertise and submission proficiency.
Key Requirements:
- Proven experience in managing solid oral and/or sterile dosage forms.
- Strong knowledge of EMA guidelines, Module 1 regional requirements, and eCTD submission systems.
- Excellent communication, planning, and leadership skills.
- Ability to collaborate effectively with cross-functional teams and regulatory authorities.
Educational Qualification: Masters degree in Pharmacy, Life Sciences, or a related discipline.
Why Join Us:
- Be part of a rapidly growing pharmaceutical company.
- Work in an innovation-driven environment contributing to global healthcare advancements.
- Opportunity to lead regulatory operations for the European market and shape our international growth journey.
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