Senior Regulatory Coordinator

Novartis India; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Novartis India in Hyderabad is seeking a Regulatory Affairs professional to coordinate readiness with line functions, country organizations, and regions for timely submissions and approvals.

You will serve as the single RA contact in NTO project teams, providing regulatory input on requirements, timelines, risks, and production transfers, while identifying risks and communicating mitigations to ensure on-time delivery.

Qualifications

• Minimum of 3 years of experience in Regulatory Affairs related areas of the pharmaceutical industry.
• Strong communication, interpersonal, negotiation, and problem-solving skills.
• Proactive, delivery-focused mindset with flexibility to meet stretch targets.
• Ability to demonstrate agility and speed while maintaining focus on timely outcomes.
• Effective planning, prioritization, and coordination of workloads across teams.
• Experience working confidently in a global matrix environment across sites and functions.
• Ability to build strong, effective relationships across teams and projects.
• Regulatory operational expertise.
• Experience with Clinical Study Reports.
• Data analysis skills.
• Document management proficiency.
• Knowledge of life sciences.
• Operational excellence capabilities.
• Understanding of regulatory compliance.

Responsibilities

• Coordinate regulatory readiness with line functions, Country Organizations, and Regions to enable on-time submissions and approvals.
• Act as the single point of contact for Regulatory Affairs, representing RA in project teams and forums, providing input on requirements, timelines, and risks.
• Proactively identify regulatory risks, gaps, and trade-offs; communicate issues and mitigations to project teams.
• Track and manage project progress, including timelines, dossier deliverables, and regulatory milestones.
• Ensure quality and compliance with global and country-specific regulatory requirements and internal policies.
• Contribute to RA GDD non-project initiatives and continuous improvement activities.
• Drive knowledge sharing and capability building through lessons learned and trainings.
• Ensure clear alignment on roles across stakeholders.
• Maintain country requirement intelligence and engage with Country Organizations.

Skills

Regulatory affairs

Communication skills

Negotiation

Problem solving

Project coordination

Global matrix experience

Data analysis

Document management

Life sciences knowledge

Operational excellence

Job description

ROLE

• Coordinate regulatory readiness with line functions, Country Organizations, and Regions to enable on-time submissions and approvals.


• Act as the single point of contact for Regulatory Affairs, representing RA in NTO project teams and global/regional forums, providing regulatory input on requirements, timelines, and risks for new submissions, LENC, and production transfers.


• Proactively identify regulatory risks, gaps, and trade-offs; communicate issues, mitigations, and key achievements to project teams to avoid delays.


• Track and manage project progress, including timelines, dossier deliverables, and regulatory milestones.


• Ensure quality and compliance with global and country-specific regulatory requirements and adherence to internal policies and processes.


• Contribute to non-project initiatives and continuous improvement activities within RA GDD.


• Drive knowledge sharing and capability building through lessons learned, trainings, and cross-functional engagements to support aligned regulatory strategies.


• Ensure clear alignment on roles and responsibilities across internal and external stakeholders.


• Maintain country requirement intelligence, including requirement lists, surveys, and direct engagement with Country Organizations.

REQUIREMENTS

• Minimum of 3 years of experience in Regulatory Affairs related areas of the pharmaceutical industry.


• Strong communication, interpersonal, negotiation, and problem-solving skills.


• Proactive, delivery-focused mindset with flexibility to meet stretch targets.


• Ability to demonstrate agility and speed while maintaining focus on timely outcomes.


• Effective planning, prioritization, and coordination of workloads across teams.


• Experience working confidently in a global matrix environment across sites and functions.


• Ability to build strong, effective relationships across teams and projects.


• Regulatory operational expertise.


• Experience with Clinical Study Reports.


• Data analysis skills.


• Document management proficiency.


• Knowledge of life sciences.


• Operational excellence capabilities.


• Understanding of regulatory compliance.