Regulatory Affairs at Graviti Pharmaceuticals
Location: Patancheru, Telangana, India
Experience: 1-3 Years
Education: B.Pharm, M.Pharm, MSc, BSc
Salary: Not Disclosed
Application Mode: Online
Skills: Time management, Flexibility, Problem-solving, Work/Life Balance
About Graviti Pharmaceuticals
Graviti Pharmaceuticals is a leading player in the pharmaceutical industry, dedicated to delivering top-notch pharmaceutical solutions through advanced research and development. With a strong emphasis on regulatory compliance, the company has gained a stellar reputation for adhering to both national and international standards. At Graviti, innovation, quality, and professional growth are integral to its culture, creating an ideal environment for those seeking to make a difference in the pharmaceutical world. The company is particularly focused on growing its domestic operations, providing ample opportunities for career advancement. Regulatory Affairs at Graviti Pharmaceuticals Regulatory Affairs at Graviti Pharmaceuticals
Job Description: Executive in Regulatory Affairs (Domestic Licensing)
This role is pivotal for ensuring that Graviti Pharmaceuticals complies with India’s regulatory requirements. As an Executive in Regulatory Affairs, you will be responsible for managing all aspects of domestic licensing. The role requires close interaction with various regulatory bodies, including the Central Drugs Standard Control Organization (CDSCO) and the Drug Control Administration (DCA), to ensure smooth licensing processes. Regulatory Affairs at Graviti Pharmaceuticals
Your primary responsibilities will include preparing and submitting license applications, coordinating with regulatory bodies, and collaborating with government officials to obtain necessary approvals for the production and R&D activities of the company. The role also involves keeping track of renewals and ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. Regulatory Affairs at Graviti Pharmaceuticals
Key Responsibilities
- Prepare and submit license applications: This includes various forms like NDA, SND, Form 30, Form 25, and CT Forms (CT 10, CT 12, CT 23) to CDSCO and DCA.
- Coordinate with regulatory bodies: Work closely with CDSCO and DCA to ensure smooth processing and approvals of domestic licenses.
- Record-keeping: Maintain up-to-date licensing documents related to both the R&D center and the production plant.
- Collaboration with government officials: Work with officials from Central Excise, Pharmexcil, Pollution Control Board, and other relevant authorities to secure necessary licenses and approvals.
- Manage renewals and registrations: Oversee the timely renewal of licenses, applications, and registrations to avoid any disruptions in operations.
- Ensure regulatory compliance: Ensure all activities align with GMP standards and other regulatory norms, particularly in relation to specific quantity export NOCs.
Regulatory Affairs at Graviti Pharmaceuticals
Why This Role Is Exciting
Graviti Pharmaceuticals offers you the chance to work at the forefront of regulatory affairs in the ever-evolving pharmaceutical industry. You’ll play a key role in ensuring that the company’s operations run smoothly by navigating the complex regulatory landscape of India’s domestic pharmaceutical market.
In addition to being a vital link between the company and various regulatory bodies, you will have the opportunity to sharpen your project management, communication, and multitasking skills. Working in this role gives you a chance to collaborate with professionals from different sectors, including government officials, which can significantly expand your network and knowledge.
Furthermore, Graviti Pharmaceuticals fosters a work culture that prioritizes work-life balance, flexibility, and problem-solving. It’s an excellent opportunity for professionals who thrive in a dynamic, fast-paced environment, where every day presents new challenges and opportunities to grow. Regulatory Affairs at Graviti Pharmaceuticals
Required Skills and Qualifications
- Educational Background: Bachelor’s or Master’s degree in Pharmacy or a related field (B.Pharm, M.Pharm, MSc, BSc).
- Regulatory Expertise: A deep understanding of domestic licensing procedures in India is essential. Experience in preparing and submitting regulatory documentation is a must.
- Knowledge of CDSCO and DCA Guidelines: Familiarity with the regulations and standards set by CDSCO and DCA, as well as GMP, is crucial for success in this role.
- Coordination and Communication: Excellent skills in working with government officials and regulatory bodies, ensuring smooth processing and approval of applications.
- Time Management: The ability to manage multiple tasks simultaneously and meet tight deadlines.
Regulatory Affairs at Graviti Pharmaceuticals
Take the Next Step in Your Career
If you’re passionate about regulatory affairs and want to make an impact in the pharmaceutical industry, this role at Graviti Pharmaceuticals is the perfect opportunity. With a focus on innovation, compliance, and professional growth, this is your chance to be part of a company that is shaping the future of medicine in India. Apply now and join a team committed to delivering high-quality pharmaceutical solutions while fostering a culture of work-life balance and personal growth! Regulatory Affairs at Graviti Pharmaceuticals