Company Description

Sunways (India) Pvt. Ltd., established in 1953 in Mumbai, India, specializes in the production of high-quality ophthalmic products under the supervision of qualified pharmacists, chemists, and microbiologists. Recognized for its robust product line, the company offers widely accepted eye drops, intraocular products for surgical procedures, and sterile preparations, alongside oral medications like capsules and syrups. With over six decades of expertise in collaboration with ophthalmic faculty, Sunways is ISO 9001-2008, WHO-GMP, and CRISIL certified. The organization has evolved from a family-run business to a skilled setup with the vision of its third generation.

Role Description

The Regulatory Affairs Manager will focus on ensuring compliance with regulatory standards and managing submissions to health authorities.



Responsibilities include maintaining quality systems, preparing and reviewing regulatory documentation, liaising with regulatory bodies, and ensuring products meet legal and safety requirements. This is a full-time, on-site role based in the Mumbai Metropolitan Region.

SOP development / reviewing

Artwork development / reviewing

Dossier preparations

CTD/ACTD guidelines

Inspection / audits

Medical devices

Ophthalmics

API DMF

Quality Assurance

FDA / ISO

Minimum qualification : B. Pharm

Exp - one year experience or Science graduate with atleast 2 years’ experience in pharmaceutical company.

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