Company Description Sunways (India) Pvt. Ltd., founded in 1953 in Mumbai, manufactures a wide range of ophthalmic products under the supervision of qualified pharmacists, chemists, and microbiologists. The company collaborates closely with medical specialists and ophthalmic faculty to develop need-based specialty formulations for preventive, diagnostic, and intraocular use in surgical procedures. In addition to eye drops and intraocular products, Sunways operates advanced manufacturing facilities for oral medications and sterile preparations. The organization holds ISO 9001:2008, WHO-GMP, and CRISIL certifications, reflecting its commitment to quality and compliance. Sunways is transitioning from a family-run business to a professionally managed setup, offering opportunities within a growing and modernizing company.
Role Description The Regulatory Affairs Manager is a full time, on-site role based in the Mumbai Metropolitan Region. This position is responsible for managing regulatory submissions for ophthalmic and pharmaceutical products,



ensuring compliance with national and international regulations, and maintaining up-to-date product registration dossiers. The role involves coordinating with production, quality assurance, and R&D; teams to gather technical documentation, reviewing labels and promotional materials for regulatory accuracy, and monitoring changes in regulatory guidelines. The manager will liaise with regulatory authorities and certification bodies, support audits and inspections, and maintain records and databases related to approvals, licenses, and certifications. The role also includes leading internal compliance initiatives, advising management on regulatory risks, and contributing to continuous improvement of regulatory processes.
Qualifications
Solid knowledge of pharmaceutical and ophthalmic regulatory frameworks, including WHO-GMP and relevant national regulations, with experience preparing and managing dossiers and regulatory submissions.
Exp

📌 Regulatory Affairs Manager (Mumbai)
🏢 Sunways (India
📍 Mumbai