Caritas Healthcare

Senior Regulatory Affairs Specialist Location: Ahmedabad, Gujarat Employment Type: Full-Time | On-site About Caritas Healthcare Pvt. Ltd. Caritas Healthcare Pvt. Ltd. is a distinguished global pharmaceutical company headquartered in India, recognized for its innovative contributions to healthcare. We specialize in the manufacture, supply, and marketing of cutting-edge pharmaceutical products serving regulated, semi-regulated, and non-regulated markets worldwide. Our unwavering commitment to innovation, regulatory compliance, and patient welfare positions us as a trusted partner in advancing global health. At Caritas, we foster an inclusive work environment where diverse perspectives are valued, and employees are empowered to excel. Position Summary We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our regulatory team in Ahmedabad. This pivotal role will manage regulatory documentation, ensure compliance with international standards, and facilitate product registrations and lifecycle management across LATAM, ASEAN, and African markets. Your expertise will directly contribute to expediting access to essential medicines, impacting millions of patients worldwide. Key Responsibilities Compile and review registration dossiers aligned with country-specific regulatory guidelines. Prepare, compile, and critically assess high-quality regulatory submissions (e.g., CTD, eCTD) for product approvals and renewals. Conduct thorough reviews of technical documents including DMF, PDR, BMR/BPR, Spec/STP, AMV, BE, and stability data. Compile comprehensive deficiency responses to address regulatory queries. Prepare and submit variations for post-approval changes in compliance with current regulatory requirements. Coordinate proactively with overseas regulatory teams, agents, and distributors to ensure timely filings. Review artwork for commercial supplies and new product launches to ensure regulatory compliance. Maintain and update internal regulatory documentation and databases systematically. Monitor global regulatory developments and assess their potential impact on product portfolios. Required Qualifications and Experience Bachelor’s or Master’s degree in Pharmacy (B. Pharm / M. Pharm). 2-3 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry. Demonstrated experience managing regulatory submissions specifically for LATAM, ASEAN, and African markets. Preferred Skills and Attributes In-depth regulatory and technical knowledge of pharmaceutical product dossiers and international submissions. Strong analytical and problem-solving capabilities. Excellent written and verbal communication skills tailored to regulatory contexts. Proven ability to work independently and collaboratively within a fast-paced, global environment. Why Join Caritas Healthcare? Become part of a purpose-driven organization with a truly global footprint. Collaborate with seasoned professionals and industry leaders committed to innovation. Gain continuous professional development and international exposure to enhance your career. Contribute meaningfully to expanding access to vital medicines in diverse global markets. Thrive in an inclusive and empowering workplace culture dedicated to diversity and growth. Application Process If you are an experienced Regulatory Affairs professional eager to contribute to a global leader in healthcare innovation, we invite you to submit your CV and cover letter to ramesh@caritashealthcare.in . We look forward to connecting with visionary talent ready to make a lasting impact. Visit us: www.caritashealthcare.com