Associate II, Regulatory Operations

alcon; Bengaluru; On-site; INR 1,100,000 - 1,500,000; Full time

Job summary

Alcon Bengaluru seeks an Associate II, Regulatory Operations to support regulatory submissions, database upkeep, and compliance with global and local regulations within the Quality & Regulatory Affairs function.

You will handle complex tasks, maintain dossiers, manage submissions for all franchises, and advise development and marketing on labeling, literature and advertising. Strong attention to detail and collaboration in a matrixed environment are essential.

Qualifications

• Experience enabling regulatory submissions and document management.
• Familiarity with global regulatory requirements (GxP) and SOPs.
• Strong attention to detail and deadlines.
• Ability to work in a cross-functional, matrixed environment.

Responsibilities

• Handle regulatory submissions and maintain submission databases.
• Prepare dossiers and oversee publishing, licensing, and labeling.
• Maintain Regulatory Affairs archives and data governance records.
• Ensure products comply with external regulations and internal standards.
• Provide guidance on product changes, quality testing, labeling, and advertising.
• Adhere to SOPs and complete required training.
• Support continuous improvement in regulatory operations.

Skills

Regulatory operations

GxP compliance

Documentation control

Cross-functional collaboration

Tools

RIM systems

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. Are you ready to join us?

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 II, Regulatory Operations (Professional Path) is primarily responsible for applying specialized knowledge to support project goals through regulatory submissions, database maintenance, and compliance with external regulations. Specifics include:

• Handle complex tasks related to regulatory operations, ensuring timely and accurate submission of regulatory 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 and attention to detail
• 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) and maintaining accurate documentation
• Ensure rigorous quality control, complete all required training, and 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.

Preferred Qualifications

• Familiarity with Unique Device Identification (UDI) requirements and data management processes across global markets, such as GUDID and EUDAMED.
• Demonstrated organizational and time management skills, with the ability to prioritize multiple projects and consistently meet deadlines.
• Strong communication and interpersonal skills, with the ability to proactively identify issues, manage risks, resolve conflicts, and drive solutions.
• Ability to work effectively in a cross-functional, matrixed environment and influence stakeholders to achieve business objectives.
• Strong attention to detail and commitment to delivering high‑quality results in a fast‑paced environment.
• Ability to adapt to changing priorities while maintaining focus on key deliverables and timelines.
• Knowledge of regulatory information management (RIM) systems and regulatory data governance principles.

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.