Alcon is Hiring Associate I, Regulatory Operations (Bangalore)

Alcon; Bengaluru; On-site; INR 450,000 - 650,000; Full time

Job summary

Alcon in Bengaluru, India, seeks an Associate I, Regulatory Operations (Professional Path) to support regulatory submissions, maintain databases, and ensure compliance with external regulations and internal standards. You will prepare dossiers, manage submissions for all franchises, and oversee submission publishing, licensing and labeling.

The role requires attention to detail, adherence to GxP and SOPs, and collaboration with development and marketing teams on product changes, labeling and

Qualifications

• Experience supporting regulatory submissions and maintaining regulatory databases.
• Rigorous attention to detail with demonstrated compliance to GxP/SOPs.
• Ability to interpret regulations and advise cross-functional teams on impact.

Responsibilities

• Handle regulatory submissions and ensure timely, accurate documentation.
• Maintain up-to-date databases of submissions and approvals.
• Prepare dossiers and manage submissions for all franchises, including labeling.
• Maintain Regulatory Affairs Archives and support tech file administration.
• Provide guidance to development and marketing on product changes, labeling, and literature.
• Ensure products comply with external regulations and internal standards.
• Audit compliance processes and participate in continuous improvement.

Job description

At Alcon, we are 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 and offer opportunities to grow your career. Together, we make a difference in the lives of our patients and customers.

This role is part of Alcon's Quality & Regulatory Affairs function, which ensures our products comply with global, local, and internal regulations and meet the strictest quality standards. 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.

Key Responsibilities

• 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 follow GxP regulations by strictly adhering to SOPs, keeping accurate and complete documentation, applying rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and supporting the organization's overall compliance. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

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.