Regulatory Affairs Assistant Manager

Job Description

We are seeking a detail-oriented and proactive Regulatory Affairs Assistant Manager to join our team at Sushen. The ideal candidate will support the preparation, submission, and maintenance of regulatory dossiers for domestic and international markets, ensuring compliance with all applicable regulatory requirements. Key Responsibilities Prepare, compile, and review regulatory dossiers (CTD/eCTD format) for submission to health authorities (e.g., USFDA, EMA, TGA, MHRA, WHO, etc.). Coordinate with cross-functional teams (R&D, QA, QC, Production) to gather required documents and technical data. Track and manage regulatory submissions and approvals. Review product labeling, artwork, and promotional materials for regulatory compliance. Handle post-approval changes, renewals, and life-cycle management of products. Respond to queries from regulatory authorities in a timely and accurate manner. Maintain up-to-date knowledge of relevant regulatory guidelines and changes. Ensure compliance with internal SOPs and global regulatory standards. Maintain and update regulatory databases and documentation repositories. Qualifications Bachelor’s or master’s degree in pharmacy, Life Sciences, or related field. 6-7 years of experience in Regulatory Affairs within the pharmaceutical industry. Familiarity with CTD/eCTD formats and global regulatory requirements. Excellent documentation, communication, and organizational skills. Strong attention to detail and ability to meet deadlines. Preferred Skills Experience in handling submissions for regulated markets (e.g., US, EU, ROW). Understanding of ICH guidelines and drug development process. Knowledge of electronic publishing tools and regulatory software. Job Type: Full-time Pay: From ₹30,000.00 per month Benefits: Life insurance Provident Fund Schedule: Day shift Ability to commute/relocate: Changodar, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required) Education: Bachelor's (Required) Work Location: In person