425410 Regulatory Specialist Submission Co-ordinator (Open)

Job Summary

The Regulatory Specialist Submission Co-ordinator plays a crucial role in the pharmaceutical industry by ensuring compliance with regulatory requirements throughout the drug development process. This position is responsible for managing submissions related to marketing applications, pre-approval, investigational, and lifecycle maintenance, while adhering to timelines and regulatory guidelines.

Responsibilities

• Deliver Marketing Application, pre-approval/investigational, and lifecycle maintenance submissions in compliance with Regulatory Authority regulations and organizational SOPs.
• Lead relevant submission teams for product regulatory authority submissions or maintenance activities associated with approved products, including renewals and site registrations.
• Provide guidance to project teams and client groups on submission-related processes and content requirements for key markets.
• Interact effectively with line and middle management, staff, and external contacts in a matrix environment.
• Adapt to shifting priorities and timelines while maintaining a flexible approach to problem-solving.
• Interpret regulations and ensure adherence to regulatory standards throughout the submission process.

Qualifications

• Awareness of the pharmaceutical industry, drug development environment, and R&D processes.
• Knowledge of Regulatory Affairs responsibilities from pre-Investigational New Drug (IND) through Phases I-IV.
• Strong communication and interpersonal skills to interact with various stakeholders.
• Ability to think flexibly and manage multiple priorities effectively.
• Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, or related discipline).
• Experience in regulatory submissions and knowledge of regulatory guidelines.

Preferred Skills

• Familiarity with specific regulatory requirements for key markets.
• Experience in leading cross-functional teams.
• Proficiency in project management tools and methodologies.

Experience

• Relevant experience in regulatory affairs or submission coordination within the pharmaceutical industry is preferred.

Environment

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

Salary

• Estimated salary range: ₹2,500,000 per annum.

Growth Opportunities

• Opportunities for career advancement within the regulatory affairs department and potential leadership roles in submission management.

Benefits

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