Pharma Regulatory Affairs Officer

As a Pharma Regulatory Affairs Officer at Syngene, you will play a crucial role in executing submissions for various licensing activities and ensuring timely approvals from regulators. Your responsibilities will include preparing and submitting applications to CDSCO, responding to regulators" queries, following up for approvals, and maintaining compliance with regulatory standards. You will be expected to collaborate with internal and external stakeholders, maintain records of submissions and approvals, liaise with State regulators for manufacturing licenses and permissions, and provide consultation to internal stakeholders and clients on national regulatory requirements. In addition, you will be responsible for preparing SOPs, updating current procedures, and keeping operating units informed about changes in rules and regulations governing product development. Your leadership capabilities will be essential in fostering a culture of collaboration, team building, continuous learning, and development within the department. To excel in this role, you should have 6-8 years of experience in pharmaceutical regulatory affairs, with a focus on making error-free submissions, attention to detail, and effective time management. Your educational background should include an M.Pharma/M.Sc. or equivalent degree, along with excellent analytical, reasoning, communication, and time management skills. At Syngene, safety is paramount, and you will be expected to adhere to safety guidelines, drive a culture of environment, health, and safety, and ensure compliance with quality standards at all times. By demonstrating alignment with our core values of Excellence, Integrity, and Professionalism, you will contribute to the success of our organization. Syngene is an equal opportunity employer, offering a collaborative and supportive work environment where your skills and capabilities will be valued and developed.,