Associate I, Regulatory Operations

Alcon; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Alcon Bengaluru is seeking an Associate I, Regulatory Operations (Professional Path) to support regulatory submissions, maintain databases, and ensure compliance with global and local regulations. You will prepare dossiers, manage submissions for all franchises, and help maintain archives.

The role requires attention to detail, ability to follow SOPs, and collaboration with development and marketing teams on product changes and labeling.

Qualifications

• Experience in regulatory operations or submissions is preferred.
• Understanding of regulatory requirements in healthcare/pharma.
• Ability to manage documentation and compliance with SOPs.

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 GxP regulations by SOPs, documentation, quality control, and training
• Meet individual job requirements and contribute to overall compliance
• Commit to continuous improvement in operations; comply with GxP and SOPs.

Skills

Regulatory knowledge

Documentation

Attention to detail

Regulatory submissions

Education

Bachelor's degree in Life Sciences or Pharmacy

Job description

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?

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 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.