Graviti Pharmaceuticals - Regulatory Manager

Description:

Job Title: Regulatory Manager - Europe Market.

Location: Hyderabad, India.

Experience: 10-12 Years.

Industry: Pharmaceuticals / Healthcare.

Employment Type: Full-time.

About the Company:

Graviti Pharmaceuticals is a sister concern of the prestigious Yashoda Group of Hospitals, Hyderabad.

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:

We are seeking a highly skilled and experienced Regulatory Manager (Europe Market) to lead and manage regulatory submissions and post-approval activities for our growing product portfolio.

The role requires strong expertise in handling solid oral and sterile dosage forms and a deep understanding of European regulatory guidelines.

Key Responsibilities:

- Evaluate and implement regulatory submission strategies for the Europe market.

- 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:

- 10-12 years of experience in pharmaceutical regulatory affairs, focusing on European market submissions.

- 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.