Graviti Pharmaceuticals Hiring Regulatory Affairs

Regulatory Affairs Openings for US & EU | Graviti Pharma Hyderabad

5–8 years Regulatory Affairs opening at Graviti Pharmaceuticals, Hyderabad. Hiring for USFDA & EU submissions and labeling activities.

Graviti Pharmaceuticals is hiring an experienced Regulatory Affairs professional for its Hyderabad location. The role focuses on regulatory submissions, labeling activities, and lifecycle management for the United States and Europe markets. This opening is suitable for candidates who have deep understanding of ANDA submissions, global compliance standards, and post‑approval regulatory workflows. The position offers a strong platform for career growth in high‑value regulatory functions, especially within the USFDA and EU landscapes.

Company Overview

Graviti Pharmaceuticals is a global pharmaceutical manufacturer known for its strong R&D capabilities and regulated market expertise. The company works across key therapeutic areas and supplies high‑quality formulations to the US and EU. With a compliance‑driven culture and robust documentation systems, Graviti maintains consistent approval success in major regulatory markets. The Hyderabad site supports advanced development programs, regulatory submissions, and market‑specific compliance activities.

Job Role & Responsibilities

Regulatory Affairs – US & EU

• Handle ANDA submissions to USFDA and EU authorities.
• Manage post‑approval regulatory activities for lifecycle maintenance.
• Prepare and review labeling components for the US and EU.
• Work on SPLs, mock‑ups, and market‑specific artwork.
• Respond to labeling deficiencies and regulatory authority questions.
• Coordinate with cross‑functional teams for submission readiness.
• Ensure compliance with evolving global regulatory guidelines.

These responsibilities support global drug approvals, regulatory transparency, and patient safety, which directly contribute to healthcare quality and international compliance.

Eligibility / Qualifications

Required Education (include related courses)

Suitable backgrounds include:

• B.Pharm, M.Pharm, M.Sc (Regulatory Affairs, Pharmaceutical Chemistry, Quality Assurance, Pharmaceutics, Industrial Pharmacy).
• Additional helpful courses: Drug Regulatory Affairs, Clinical Research & Regulatory Compliance, GMP Documentation, Global Pharmaceutical Regulations.

Experience

• 5 to 8 years in Regulatory Affairs for regulated markets.
• Strong hands‑on experience in labeling activities for the USA & EU.
• Solid understanding of ANDA submissions and lifecycle management.

Location & Salary

• Location: Hyderabad, Telangana.
• Salary details depend on experience and company norms but generally align with senior‑level Regulatory Affairs positions in high‑compliance markets.

Application Process

Interested candidates can apply by emailing their profile to:

• careers@gravitipharma.com

Ensure your resume highlights labeling experience, ANDA expertise, and successful regulatory submissions.

FAQs

What experience is required for this role?

A minimum of 5–8 years in Regulatory Affairs focusing on USFDA and EU submissions.

Is labeling experience mandatory?

Yes. The role specifically requires strong experience in labeling for US and EU markets.

Are freshers eligible?

No. This is a senior‑level regulatory position.

What type of submissions will I handle?

Primarily ANDA submissions, post‑approval updates, and labeling components.

How do I apply?

Send your resume to careers@gravitipharma.com.

Summary Table

+----------------------+--------------------------------------------------+
| Company              | Graviti Pharmaceuticals                          |
+----------------------+--------------------------------------------------+
| Vacancies            | Regulatory Affairs – US & EU (1 Position)        |
+----------------------+--------------------------------------------------+
| Required Education   | B.Pharm, M.Pharm, M.Sc, RA/QA/Pharmaceutics      |
+----------------------+--------------------------------------------------+
| Experience           | 5–8 years in Regulatory Affairs                  |
+----------------------+--------------------------------------------------+

Tagged as: Pharma Jobs in Hyderabad