Job Summary
Join a leading pharmaceutical organization in Mumbai as a Manager – Regulatory Publishing, where you will lead a high-performing team delivering high-quality submission publishing outputs. With a strong focus on compliance, process optimization, and people development, this role is ideal for experienced regulatory affairs professionals with deep expertise in eCTD and publishing tools. This position is central to managing submissions across global markets including RoW, EU, and the US.
Key Responsibilities
Lead and mentor a team of submission publishers ensuring timely, accurate, and compliant regulatory submissions.
Troubleshoot submission issues and ensure high-quality output to health authorities.
Drive first-time-right approach across teams and stakeholders.
Identify and implement process improvements and efficiency measures.
Manage resource planning, workload distribution, and publishing workflows.
Collaborate across operations, affiliates, and regional leads for seamless regulatory output.
Stay updated with global regulatory changes and guide the team in adapting accordingly.
Support technical tool upgrades, testing, and documentation processes.
Train internal teams and end users on publishing systems and tools.
Optimize ticketing processes and reduce end-user errors.
Participate in eCTD implementation kick-off meetings across new countries.
Contribute to hiring, onboarding, performance evaluation, and competency development of team members.
Required Skills & Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
10–12 years of experience in submission publishing or regulatory affairs.
5–6 years of proven people management and team leadership experience.
Expert knowledge in eCTD publishing and troubleshooting.
Experience with publishing tools (e.g., ArisG) and regulatory systems.
Exposure to global markets including RoW (EM), EU, and ideally the US.
Strong understanding of pharmaceutical product lines, including vaccines.
Ability to create SOPs, training material, and simplified work guides.
Perks & Benefits
Opportunity to work in a globally recognized pharma company.
Leadership role with cross-functional visibility and impact.
Career advancement and competency development opportunities.
Access to industry-standard tools and technologies.
Inclusive and collaborative work culture.
Company Description
A globally leading pharmaceutical company, renowned for innovation and compliance in healthcare and life sciences. Focused on delivering high-quality therapeutic solutions, the organization champions regulatory excellence, operational efficiency, and talent development.
Work Mode: On-site – Mumbai, India
Call-to-Action
If you are a regulatory publishing expert ready to lead impactful global submissions and drive operational excellence, apply now to advance your career in a high-growth, compliance-driven environment.
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