Executive - Regulatory Affairs

JOB RESPONSIBILITIES -

Total Experience Required: Minimum 4 years in the Core Regulatory Affairs Department
Qualification: B.Pharma/ M. Pharma

• Minimum 3 years of experience in the compilation and preparation of dossiers for semi-regulated and regulated markets.
• Analyze and respond to inquiries from regulatory agencies and customers worldwide, ensuring timely submissions within set deadlines.
• Maintain a well-organized and up-to-date regulatory filing system, including databases and chronologies, for easy tracking of changes made to documents submitted to agencies or partners.
• Proactively update existing internal regulatory guidelines and develop new ones as needed to ensure alignment with current requirements.
• Continuously stay informed about the latest regulations, guidance documents, and standards set forth by the FDA, international regulatory bodies, and domestic agencies relevant to the company's products.
• Conduct thorough reviews of CMC (Chemistry, Manufacturing, and Controls) documents within established timelines.
• To co-ordinate/ follow up for technical departments like R&D, QA, QC, ADL and Manufacturing, for arranging the documents required for preparation/ compilation of Dossiers within defined timelines.
• Managing the Registration Sample to deliver it to the customers within defined timelines.
• Timely submission of dossier/ post approval submissions to the various Regulatory Authorities and the subsequent life cycle management.
• To collect and compile the necessary documentation for the raw materials (Active Pharmaceutical Ingredients (API) and excipients) used in the manufactured batches intended for the registration of medicinal products in foreign countries. Additionally, to address and resolve any queries raised by government authorities during the registration/reregistration process.
• Take ownership of additional duties assigned to support the Regulatory Affairs department.