425660 Regulatory Specialist, Submission Coordination; SDE, LCM (Open)

Job Summary

The Regulatory Specialist is responsible for delivering marketing applications and lifecycle maintenance submissions, including product renewals, site submissions, and variations. This role ensures compliance with Regulatory Authority regulations and guidelines, as well as organizational Standard Operating Procedures (SOPs). The specialist will collaborate with relevant submission teams and coordinate submission activities to meet agreed timelines.

Responsibilities

• Deliver marketing applications and lifecycle maintenance submissions in compliance with regulatory guidelines and organizational SOPs.
• Coordinate Marketing Submission Requests (MSR) for various types of submissions, executing agreed dossier strategies independently.
• Assist in scenario planning when multiple regulatory strategies are considered.
• Identify and escalate risks associated with submission delivery that may impact the business.
• Participate in submission teams to support regulatory authority submissions or maintenance activities for approved products.
• Mentor and train other team members as required.

Qualifications

• Degree in a biological, healthcare, or scientific discipline, or extensive experience in the Regulatory Affairs area.
• Understanding of the pharmaceutical industry, research and development (R&D) processes, and objectives.
• Ability to interpret regulations and guidelines related to pharmaceutical product registration and manufacturing.
• Strong written and verbal communication skills, with the ability to present information clearly and concisely.
• Excellent organizational skills, attention to detail, and a commitment to delivering high-quality output in a timely manner.
• Ability to proactively identify and mitigate risks and potential bottlenecks.
• Experience in leading or co-leading multidisciplinary team meetings and facilitating discussions regarding submission content and timelines.

Preferred Skills

• Familiarity with regulatory submission processes and documentation.
• Experience in process improvement initiatives within a regulatory context.

Experience

• Relevant experience in Regulatory Affairs, particularly in submission coordination and lifecycle management.

Environment

• Work setting is hybrid, combining both in-office and remote work. The position is based in Bengaluru Luxor North Tower.

Salary

• Estimated salary range: ₹2,500,000.

Growth Opportunities

• Opportunities for career advancement within the regulatory affairs department and related areas of the organization.

Benefits

• Comprehensive benefits package including health insurance, paid leave, and flexible work policies.