Sr. Executive / Executive - Regulatory Affairs

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.