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.
- Experience collaborating with cross-functional teams such as production, quality assurance, and R&D; to compile technical documentation and support audits and inspections.




- Strong skills in documentation management, data analysis, and report writing, with attention to detail in reviewing labels, packaging, and promotional materials for regulatory compliance.
- Effective communication and stakeholder management skills to interact with regulatory authorities, certification bodies, internal leadership, and external partners.
- Ability to interpret and implement updates to regulatory guidelines, manage timelines and multiple projects, and drive continuous improvement in compliance processes.
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field; prior experience in regulatory affairs within pharmaceuticals or ophthalmic products is strongly preferred.
- Proficiency in using standard office and documentation software, with robust organizational skills and a structured, detail-oriented work style.

Company Description Sunways (India) Pvt. Ltd., founded in 1953 in Mumbai, India, is a specialized manufacturer of ophthalmic products developed under the supervision of qualified pharmacists, chemists, and microbiologists. The company collaborates closely with medical specialists to create need-based specialty formulations, including widely accepted eye drops for preventive and diagnostic use and acclaimed intraocular products for surgical procedures. Its manufacturing facilities also produce oral medications such as capsules and syrups, as well as sterile preparations. Sunways is ISO 9001-2008, WHO-GMP, and CRISIL certified, reflecting its commitment to quality and compliance. The company is transitioning from a family-run business to a professionally managed organization, offering growth opportunities in a dynamic environment. Role Description This is a full-time,



on-site Regulatory Affairs Manager role based in the Mumbai Metropolitan Region.

The Regulatory Affairs

Manager will oversee regulatory compliance for ophthalmic and other pharmaceutical products, ensuring adherence to national and international regulatory requirements.

Responsibilities include preparing, reviewing, and submitting regulatory documentation and dossiers, maintaining approvals and licenses, and coordinating with regulatory authorities and certification bodies. The role will collaborate with production, quality assurance, and quality control teams to support and improve the quality system, manage audits, and drive continuous improvement in documentation and processes. The manager will also monitor regulatory changes, provide internal guidance on impact, and support product lifecycle management from development through post-marketing.

Qualifications

- Candidates should possess strong skills in Regulatory Affairs and Regulatory Submissions for pharmaceutical and ophthalmic products.
- Candidates should possess solid understanding of Regulatory Compliance and Regulatory Requirements applicable to Indian and global health authorities.
- Candidates should possess experience with Quality System management, including documentation, audits, and corrective and preventive actions.
- Relevant academic background such as a degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Experience in pharmaceutical or medical device regulatory affairs, preferably in ophthalmic products or sterile manufacturing.
- Ability to interpret and apply regulatory guidelines, strong attention to detail, and effective written and verbal communication skills.
- Demonstrated ability to work collaboratively with cross-functional teams and manage multiple projects and deadlines.
- Familiarity with ISO, WHO-GMP, and other quality and compliance standards is highly beneficial.

- SOP development / reviewing
- Artwork development / reviewing
- Dossier preparations
- CTD/ACTD guidelines
- Inspection / audits
- Medical devices
- Ophthalmics
- API DMF
- Quality Assurance
- FDA / ISO

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