Senor regulatory affairs specialist
Senior Regulatory Affairs Specialist Location: Ahmedabad, Gujarat About Caritas Healthcare Pvt. Ltd. Caritas Healthcare Pvt. Ltd. is a leading pharmaceutical company worldwide, based in India. At Caritas, we are engaged in the manufacture, supply, and marketing of a wide range of avant-garde pharmaceutical products , catering to regulated, semi-regulated, and non-regulated markets across the globe . Our commitment to innovation, compliance, and patient welfare makes us a trusted partner in global healthcare. Role Overview We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our Regulatory team in Ahmedabad. The role involves managing regulatory documentation, ensuring compliance with international regulatory requirements, preparing registration dossiers, and supporting product registrations and lifecycle management across LATAM, ASEAN, and African markets. Education & Experience Education: B. Pharm / M. Pharm Experience: 2-3 experiences in Regulatory Affairs within the pharmaceutical industry preferred Markets Handled: Specific hands-on experience in LATAM, ASEAN, and African regulatory submissions is essential Key Responsibilities Compilation and review of registration dossiers as per country-specific guidelines and requirements. Preparation, compilation, and review of high-quality regulatory submissions (e.g., CTD, eCTD) for product approvals and renewals. Review all technical documents (DMF, PDR, BMR/BPR, Spec/STP, AMV, BE, Stability, etc.). Compilation of deficiency responses for product submissions. Preparation and submission of variations for post-approval changes. Review proposals for post-approval changes as per current regulatory guidance. Communicate and coordinate with overseas regulatory teams, agents, and distributors to ensure timely filing. Review artworks for commercial supplies and new product launches. Maintain and update internal regulatory documentation and databases. Monitor global regulatory changes and assess their potential impact on products. Preferred Candidate Profile Strong regulatory and technical knowledge Proficiency in managing international dossiers and submissions Strong analytical and problem-solving abilities Excellent written and verbal communication skills Ability to work independently and collaboratively in a fast-paced environment Why Join Caritas Healthcare? Be part of a purpose-driven organization with a global footprint Work alongside experienced professionals and industry leaders Play a pivotal role in expanding access to essential medicines worldwide 📧 Apply Now: ramesh@caritashealthcare.in 🌐 Visit Us: www.caritashealthcare.com
