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

Job Title: ADL Officer/Executive Location: Changodar , Ahmedabad, Gujarat, India Department: Analytical Development Laboratory (ADL) Employment Type: Full-Time We are seeking a dedicated and detail-oriented Associate to join our Analytical Development Laboratory (ADL) team. The successful candidate will play a pivotal role in developing, validating, and executing analytical methods to ensure the quality and compliance of our pharmaceutical products. Key Responsibilities Method Development & Validation : Develop, optimize, and validate analytical methods for raw materials, intermediates, and finished products using techniques such as HPLC, GC, FTIR, and UV-Vis spectroscopy, adhering to ICH guidelines. Routine Analysis : Conduct routine quality control tests on pharmaceutical products to ensure compliance with company and regulatory standards. Analyze raw materials, in-process samples, and finished products for various physical and chemical parameters. Documentation : Maintain accurate and detailed laboratory records, including test results, equipment logs, and validation documents. Prepare and review standard operating procedures (SOPs) and analytical method documents. Regulatory Compliance : Ensure all activities comply with GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) regulations. Support regulatory audits and inspections by preparing necessary documentation and reports. Equipment Calibration & Maintenance : Ensure proper calibration and maintenance of laboratory equipment. Troubleshoot analytical instruments and coordinate repairs as needed. Team Collaboration : Collaborate closely with formulation, R&D, and production teams to support product development and troubleshooting. Engage with cross-functional teams on various projects. Qualifications & Skills Bachelor's or Master's degree in Science (Chemistry, Biochemistry) or Pharmacy. Proficiency in analytical techniques such as HPLC, GC, FTIR, and UV-Vis spectroscopy. Familiarity with regulatory guidelines (e.g., ICH, FDA, EMEA). Strong attention to detail and excellent organizational skills. Effective communication and teamwork abilities. Freshers & Experienced both can apply. Why Join Us? Be part of a dynamic team committed to excellence in pharmaceutical industry. We offer opportunities for professional growth, continuous learning, and the chance to make a meaningful impact on healthcare. Job Types: Full-time, Permanent, Fresher Pay: ₹21,000.00 - ₹35,000.00 per month Benefits: Commuter assistance Life insurance Provident Fund Education: Bachelor's (Required) Experience: pharmaceutical: 2 years (Required) Analytical chemistry: 1 year (Preferred) Work Location: In person

Job Title: Executive Warehouse Location: Changodar , Ahmedabad, Gujarat, India Department: Supply Chain Employment Type: Full-Time Key Responsibilities Manage Raw Material Stores Manage Finished Goods stores Inventory Management Material Handling Product Dispatches GMP Compliances Job Types: Full-time, Permanent, Fresher Pay: ₹25,000.00 - ₹35,000.00 per month Benefits: Commuter assistance Education: Bachelor's (Required) Experience: Store management: 2 years (Required) Inventory management: 2 years (Preferred) Work Location: In person

Job Title: Production Executive Location: Changodar , Ahmedabad, Gujarat, India Department: Manufacturing Employment Type: Full-Time Key Responsibilities Manage production activities Batch documentation Achieving Production Targets Ensure quality outputs GMP Compliances Job Types: Full-time, Permanent, Fresher Pay: ₹25,000.00 - ₹35,000.00 per month Benefits: Commuter assistance Education: Bachelor's (Required) Experience: pharmaceutical production: 2 years (Required) Production management: 2 years (Preferred) Work Location: In person

Job Title: Production Officers Location: Changodar , Ahmedabad, Gujarat, India Department: Manufacturing Employment Type: Full-Time Key Responsibilities Supervise Manufacturing Operations Shift Management Coordination with QA / QC Achievement of Production Targets GMP Complinaces Job Types: Full-time, Permanent, Fresher Pay: ₹20,000.00 - ₹25,000.00 per month Benefits: Commuter assistance Education: Bachelor's (Required) Experience: Pharmaceutical Production: 2 years (Required) Production: 2 years (Preferred) Shift availability: Day Shift (Preferred) Night Shift (Preferred) Work Location: In person