Senior Associate, Regulatory Affairs CMC

Alcon; Bengaluru; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Alcon is seeking a Sr. Associate, Chemistry Manufacturing & Control (CMC) within the Quality & Regulatory Affairs function.

The role involves supporting global CMC regulatory strategies and maintenance for biologics, pharmaceuticals, and devices, and assisting in preparing CMC submissions for market registrations, progress reports, and supplements. You will identify regulatory risks, develop alternative actions, and assess new regulations for necessary changes, while adhering to SOPs and

Qualifications

• Experience supporting global CMC regulatory strategies and submissions.
• Familiarity with GxP regulations and SOPs; maintain quality documentation.

Responsibilities

• Support and manage registration maintenance activities for approved products.
• Assist in developing and implementing global CMC regulatory strategies for biologics, pharmaceuticals, and devices.
• Help prepare CMC submissions, including market registrations, progress reports, annual reports, supplements, amendments, and periodic experience reports.
• Participate in identifying risk areas and developing alternative courses of action.
• Assess the impact of new regulations and implement necessary changes.
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, ensuring quality control, and completing required training.
• Meet individual job requirements and contribute to organizational compliance and continuous improvement with regulatory requirements.

Skills

CMC regulatory strategies

CMC submissions

GxP regulations

Documentation & training

Job description

Job Profile Summary

Develops and implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices. Prepares and directs the development of CMC submissions including initial market registrations, progress reports, supplements, amendments, and/or periodic experience reports. Represents company during communications and meetings with health authorities. Interacts and negotiates with regulatory agencies in order to expedite approval of pending registration and answer any questions. Participates in identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes, leads development of company policy and positions on draft regulations and guidance.

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 Sr. Associate, Chemistry Manufacturing & Control (CMC) (Professional Path), is primarily responsible for supporting global CMC regulatory strategies and maintenance for biologics, pharmaceuticals, and devices. You will assist in preparing CMC submissions, support product registration preparation, and support and manage maintenance activities of approved products. You’ll also identify regulatory risks, develop alternative solutions, and assess new regulations for necessary changes.

Specifics Include:

• Support and manage registration maintenance activities for the approved products
• Assist in developing and implementing global CMC regulatory strategies for biologics, pharmaceuticals, and devices
• Help prepare CMC submissions, including market registrations, progress reports, annual reports, supplements, amendments, and periodic experience reports
• Participate in identifying risk areas and developing alternative courses of action
• Assess the impact of new regulations and implement necessary changes
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, ensuring quality control, and completing required training
• Meet individual job requirements and contribute to overall organizational compliance and continuous improvement with regulatory requirements

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.