Executive/Sr Executive- Liaisoning

Role & responsibilities

• Serve as the regulatory point of contact in Delhi, closely coordinating with CDSCO, DCGI, and State Drug Control Authorities.
• Prepare, compile, and submit regulatory applications for New Drug NOCs, licenses, and market approvals.
• Regularly visit CDSCO and associated offices to submit documents, attend meetings, and resolve regulatory queries.
• Ensure complete adherence to Indian pharmaceutical regulations and maintain consistent communication with internal and external stakeholders.
• Collaborate with internal teams at Hyderabad HQ and Plant to gather and validate technical documentation required for submissions.
• Track and report the status of applications; proactively follow up for deficiency letters or pending matters.
• Maintain a comprehensive record of submissions, approvals, renewals, and correspondence.
• Support regulatory audits and ensure all licensing and compliance records are kept up to date.

Qualifications:

• Bachelors or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Life Sciences.
• 5–8 years of experience in Regulatory Affairs, specifically involving liaison with Indian drug regulatory authorities.
• In-depth knowledge of the Drugs & Cosmetics Act, 1940 and associated Rules.
• Strong verbal and written communication skills.
• Proficient in MS Office and regulatory documentation management systems.