indeed
Associate II, Regulatory Operations
Alcon
Karnataka, IND
Full-time
Onsite
Discovered 2 weeks ago
Regulatory operationsRegulatory submissionsRegulatory databasesDossier preparationSubmission publishingLicensing and labeling
Free
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Regulatory operationsRegulatory submissionsRegulatory databases
Role Overview
The Associate II, Regulatory Operations role is part of Alcon's Quality and Regulatory Affairs function.
The role supports regulatory submissions, database maintenance, product compliance, and regulatory operations across product franchises and global markets.
Key Skills for This Role
Regulatory operationsRegulatory submissionsRegulatory databasesDossier preparationSubmission publishingLicensing and labeling
Full Job Posting
About Alcon
Alcon develops products and services focused on eye health and describes a culture centered on innovation, progress, and career development.
Role Overview
The Associate II, Regulatory Operations role is part of Alcon's Quality and Regulatory Affairs function.
The role supports regulatory submissions, database maintenance, product compliance, and regulatory operations across product franchises and global markets.
Core Responsibilities
- Handle complex regulatory operations tasks and submit documents accurately and on time.
- Maintain databases of submissions and approvals, Regulatory Affairs archives, and technical file administration.
- Prepare dossiers and manage submission publishing, licensing, and labeling.
- File product notifications, approval applications, and quality testing results with regulatory agencies.
- Interpret proposed regulations and advise management on their impact.
- Implement and audit compliance processes.
- Guide development and marketing teams on product changes, testing, labeling, literature, and advertising.
- Follow GxP regulations and SOPs, maintain documentation, complete quality control, and support continuous improvement.
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