Graviti Pharmaceuticals is committed to delivering high-quality pharmaceutical solutions through rigorous R&D and compliance with national and international regulatory standards. With a focus on expanding operations in the domestic market, the company fosters innovation and encourages professional growth.
Job Description: Executive in Regulatory Affairs (Domestic Licensing)
This position involves handling domestic licensing activities, ensuring compliance with the regulatory requirements of India’s pharmaceutical industry. As an Executive in Regulatory Affairs, you will manage license applications, coordinate with regulatory bodies, and interact with government officials to obtain necessary approvals.
Key Responsibilities
- Prepare and submit license applications, including NDA, SND, Form 30, Form 25, Form CT 10, CT 12, and CT 23 to CDSCO and DCA.
- Coordinate with CDSCO and DCA for the smooth processing of domestic licenses.
- Record and maintain licensing documents related to the R&D center and production plant.
- Collaborate with government officials from Central Excise, Pharmexcil, Pollution Control Board, and other regulatory authorities to obtain licenses.
- Manage license renewals, applications, and registrations to ensure timely completion.
- Ensure compliance with GMP standards and regulatory norms for specific quantity export NOCs.
Required Skills and Qualifications
- Bachelor’s/Master’s degree in Pharmacy or related field.
- In-depth knowledge of domestic licensing procedures in India.
- Experience with regulatory documentation and compliance.
- Strong coordination and communication skills for interacting with government officials and regulatory bodies.
- Familiarity with CDSCO, DCA guidelines, and GMP standards.
- Ability to manage multiple tasks and meet deadlines.
