426230 Regulatory Specialist Submission Delivery Excellence LCM (Open)

Job Summary

The Regulatory Specialist is responsible for ensuring the timely and accurate delivery of regulatory submissions for Rest of the World (ROW) markets. This role involves coordinating with various functional teams and maintaining compliance with regulatory guidelines, ultimately contributing to the organization's goals of effective product management and regulatory excellence.

Responsibilities

• Deliver assigned submissions to Project Lead, Senior Submission Coordinator, or relevant stakeholders, ensuring adherence to agreed timeframes and content requirements.
• Coordinate maintenance activities for approved products, including product renewals, label harmonization, PBRER submissions, site registrations, tenders, and variations.
• Follow organizational processes and written standards to achieve right-first-time delivery.
• Utilize regulatory intelligence resources to determine data package requirements for submissions.
• Maintain regular communication with line managers, technical leads, and functional teams to execute dossier strategies and escalate any business-impacting issues.
• Ensure the quality of both personal and team submissions, maintaining compliance with regulatory guidelines.
• Manage multiple project assignments of varying complexity simultaneously.
• Demonstrate learning agility to understand the internal and external regulatory environment.
• Build organizational networks and collaborate effectively with team members.
• Attend knowledge exchanges and training sessions to enhance knowledge of regulatory affairs and processes.
• Participate in process improvement initiatives as required.

Qualifications

• Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs).
• Strong understanding of regulatory submission processes and requirements.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a team environment.
• Strong organizational and project management skills.
• Proficiency in utilizing regulatory intelligence resources.
• Attention to detail and commitment to quality.
• Demonstrated ability to manage multiple projects effectively.

Preferred Skills

• Experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Familiarity with global regulatory requirements and guidelines.
• Knowledge of submission types such as PBRER, site registrations, and variations.

Experience

• Minimum of 3-5 years of experience in regulatory affairs or a related field.

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 potential leadership roles.