Job Title: Manager – Regulatory Publishing
Location: Mumbai, India
Work Mode: On-site
Experience: 10–12 years
Salary: Not specified
Job Summary:
Join a leading pharmaceutical organization as a Manager – Regulatory Publishing based in Mumbai. This role demands in-depth expertise in eCTD submission publishing and global regulatory requirements. As a team leader, you will oversee a high-performing group of regulatory publishers, drive quality and compliance for submissions across markets including RoW, EU, and US, and contribute to process optimization, training, and regulatory innovation.
Key Responsibilities:
Lead a team of regulatory publishers to deliver compliant and high-quality submissions.
Resolve publishing errors and troubleshoot technical challenges with eCTD systems.
Drive “first-time-right” culture by educating teams and stakeholders on best practices.
Collaborate cross-functionally to ensure regulatory submissions meet timelines and quality standards.
Analyze workload vs. resource allocation to optimize team performance and delivery.
Stay updated with global regulatory changes and adapt publishing practices accordingly.
Support eCTD implementation projects, upgrades, and user acceptance testing (UAT).
Train teams and users on publishing tools; create simplified guides and documentation.
Coordinate with ArisG for publishing tool enhancements and issue resolution.
Drive continuous improvement and implement value-adding initiatives across publishing operations.
Evaluate team performance, manage career development, and lead hiring/onboarding.
Required Skills & Qualifications:
Bachelor's or Master’s degree in Pharmacy, Life Sciences, or related discipline.
10–12 years of experience in regulatory publishing or regulatory affairs.
Minimum 5–6 years of experience in people management.
Strong technical expertise in eCTD publishing, troubleshooting, and submission systems.
Experience with global regulatory markets – RoW (EM), EU, and preferably US.
Proficiency in ArisG or other publishing tools.
Strong communication, leadership, and problem-solving skills.
Demonstrated ability to optimize publishing processes and drive efficiency.
Perks & Benefits:
Opportunity to lead regulatory operations for global submissions.
Exposure to international regulatory frameworks and publishing platforms.
Career advancement in regulatory affairs and leadership roles.
Skill development through advanced training and cross-functional collaboration.
Company Description:
A leading pharmaceutical company with a strong global presence, offering innovative healthcare solutions and a commitment to regulatory excellence. We empower teams to deliver high-quality, compliant submissions that accelerate market access worldwide.
Work Mode:
On-site – Mumbai, India
Call to Action:
Are you ready to lead a global regulatory publishing team and drive compliance excellence? Apply now to join a high-impact regulatory function at the forefront of pharmaceutical innovation.
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