Regulatory Affairs Professional

Company Description

Graviti Pharmaceuticals, established in Hyderabad, India, is a research-driven company specializing in the production of high-quality and complex generic formulations. The organization focuses on developing modified-release formulations, bio, stability-sensitive molecules, and innovative drug delivery platforms. Known for its excellence in manufacturing, Graviti Pharmaceuticals adheres to and exceeds regulatory standards, ensuring superior-quality products. Our values of reliability, integrity, and transparency form the foundation of enduring partnerships and trust.

Role Description

This is a full-time, on-site role located in Hyderabad for a Regulatory Affairs Professional. In this role, you will manage the preparation, submission, and maintenance of regulatory documents to ensure compliance with applicable guidelines and regulations. You will collaborate with cross-functional teams to address regulatory requirements, monitor regulatory changes, and provide strategic guidance for product development. Other responsibilities include liaising with health authorities and managing dossier submissions and regulatory timelines effectively.

Specialty in Europe and Us markets

Experience : 5-8 years

Qualifications

• Comprehensive knowledge of regulatory guidelines, dossier preparation, and submission requirements.
• Proficiency in regulatory documentation, compliance management, and interpretation of regulatory updates.
• Strong organizational, analytical, and project management skills to handle multiple tasks efficiently.
• Excellent communication, collaboration, and problem-solving skills to work with cross-functional teams and regulatory bodies.
• Ability to adapt to changing guidelines and anticipate regulatory challenges in the pharmaceutical industry.
• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field is preferred.
• Prior experience in regulatory affairs within the pharmaceutical sector is highly desirable.