Associate II, Regulatory Operations

Support Alcon's Quality & Regulatory Affairs function through regulatory submissions, regulatory database maintenance, compliance activities, and regulatory operations across product franchises.

Apply specialized regulatory-operations knowledge to support project goals and ensure products meet global, local, internal, and customer requirements.

Handle complex regulatory-operations activities while ensuring regulatory documents are submitted accurately and within required timelines.

Prepare regulatory dossiers and manage submissions across all applicable franchises.

Oversee submission publishing, licensing, and labeling activities.

File product notifications, approval applications, and quality-testing results with government and regulatory agencies.

Maintain accurate and up-to-date databases covering submissions and approvals.

Maintain Regulatory Affairs Archives.

Perform Tech File Administration.

Maintain complete and accurate regulatory documentation.

Support regulatory information management and data-governance activities.

Ensure submission and approval information remains current and reliable.

Follow established procedures while exercising appropriate job-related decision-making authority.

Ensure products comply with external regulations, internal standards, and customer requirements.

Interpret proposed regulations and advise management regarding their potential impact.

Implement and audit compliance processes.

Follow Good Practice (GxP) requirements and applicable Standard Operating Procedures (SOPs).

Maintain rigorous quality control and complete all required compliance training.

Contribute to continuous improvement of regulatory operations.

Provide guidance to development and marketing teams concerning product changes, quality testing, labeling, literature, and advertising.

Work effectively within a cross-functional and matrixed organization.

Influence stakeholders to achieve regulatory and business objectives.

Proactively identify issues, manage risks, resolve conflicts, and drive appropriate solutions.

Preferred knowledge of Unique Device Identification (UDI) requirements and regulatory data-management processes across global markets.

Relevant systems and data environments include GUDID and EUDAMED.

Knowledge of Regulatory Information Management (RIM) systems and regulatory data-governance principles is preferred.

Prioritize multiple regulatory projects and consistently meet deadlines.

Maintain strong attention to detail and high-quality output in a fast-paced environment.

Adapt to changing priorities while maintaining focus on key deliverables and timelines.

Demonstrate strong organizational, time-management, communication, and interpersonal skills.

Full-time position in Bangalore, India.

Remote type is listed as Not applicable, indicating an onsite/non-remote role.

Part of Alcon's Quality & Regulatory Affairs organization supporting global and local regulatory compliance.