Regulatory Operations Associate

Alcon Laboratories India Pvt Ltd; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Alcon Laboratories India Pvt Ltd in Bengaluru is seeking an Associate I, Regulatory Operations to support global regulatory submissions, maintain dossiers, and ensure compliance with applicable regulations.

You will manage submission publishing and archives, advise development and marketing on product changes, and contribute to continuous improvement within the Quality & Regulatory Affairs function.

Qualifications

• Experience in regulatory submissions and archives management.
• Knowledge of GxP and SOPs.

Responsibilities

• Apply specialized knowledge to perform tasks and achieve objectives.
• Handle regulatory submissions, ensuring timely and accurate submission of documents.
• Maintain databases of submissions and approvals.
• Prepare dossiers, manage submissions for all franchises, and oversee submission publishing, licensing, and labeling.
• Maintain Regulatory Affairs Archives and Tech File Administration.
• Follow procedures with decision‑making authority, requiring job‑related training, attention to detail, and reliability.
• Ensure products comply with external regulations, internal standards, and customer requirements.
• File product notifications, approval applications, and quality testing results with government and regulatory agencies.
• Interpret proposed regulations and advise management on their impact.
• Implement and audit compliance processes.
• Provide guidance to development and marketing teams on product changes, quality testing, labeling, literature, and advertising.
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, ensuring quality control, and completing required training.
• Meet individual job requirements and contribute to overall compliance of the organization.
• Commit to continuous improvement in operations.

Skills

Regulatory knowledge

Job description

Associate I, Regulatory Operations Job Description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers.

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Associate I, Regulatory Operations (Professional Path) is primarily responsible for supporting project goals by handling regulatory submissions, maintaining databases, and ensuring compliance with external regulations.

You will prepare dossiers, manage submissions, and maintain Regulatory Affairs Archives.

Specifics Include:

• Apply specialized knowledge to perform tasks and achieve objectives
• Handle operational aspects of regulatory submissions, ensuring timely and accurate submission of documents
• Maintain up-to-date databases of submissions and approvals
• Prepare dossiers, manage submissions for all franchises, and oversee submission publishing, licensing, and labeling
• Maintain Regulatory Affairs Archives and Tech File Administration
• Follow procedures with decision‑making authority, requiring job‑related training, attention to detail, and reliability
• Ensure products comply with external regulations, internal standards, and customer requirements
• File product notifications, approval applications, and quality testing results with government and regulatory agencies
• Interpret proposed regulations and advise management on their impact
• Implement and audit compliance processes
• Provide guidance to development and marketing teams on product changes, quality testing, labeling, literature, and advertising
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
• Meet individual job requirements and contribute to overall compliance of the organization
• Commit to continuous improvement in operations

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.

Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.

Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Experience Level Mid Level