Sr. Manager - Regulatory Operations & Publishing

Job Title:

Sr. Manager - Regulatory Operations & Publishing

Business Unit:

Regulatory & Business Continuity 

Job Grade

G9

Location :

Gurgaon

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Summary

• Partners with leaders across the organization to be the ‘face of the asset’ from regulatory operations perspective
• To manage the regulatory submissions strategy and operational activities across the globe submission management, data archival, data Security, data retrieval and management, Amplexor’s Regulatory Information Management System (RIMS), etc
• To provide strategic and regulatory operational direction for all generic products
• To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process
• To manage End to End Vendor Management activities formulate, develop and execute a comprehensive regulatory submission strategy integrating regulatory requirements
• To ensure global regulatory compliance, drive digital transformation, and implement data standardization initiatives to support seamless regulatory submissions
• To forecast operational activities and prepare inhouse/outsourcing plan

To Oversee hiring of new talent for the team

Area Of Responsibility

1. Global Regulatory Operations Leadership

• Lead global regulatory operations teams responsible for submission management, publishing, labelling, and regulatory systems governance.
• Provide strategic, tactical, and operational direction and guidance to product teams for assigned inline and/or pipeline assets in one or more therapeutic areas
• Establish metrics-driven governance, including KPIs, productivity dashboards, and quality indicators to monitor performance globally.
• Oversee the process improvement initiatives such as digital automation and AI-enabled tools to improve operational efficiency and quality.

1. Publishing and Submission Management

• Oversee Publishing activity (eCTD and Non eCTD), review, validate and dispatch the submission across globe as per the requirements of respective health agencies
• Manage Regulatory lifecycle for all in-house and outsourced activities
• Oversee validation, QC, and lifecycle management of all regulatory submissions using approved systems (e.g., Amplexor, PharmaReady, SubmitPro etc.)
• Maintain submission readiness and ensure adherence to ICH and regional technical specifications.
• Implement global submission standards, templates, and SOPs to harmonize processes across all functions, LRAs and vendors.
• Oversee the tracking, maintaining and submitting the post marketing commitments and post marketing requirements for all generic products
• Oversee the archival, maintenance and security measures of all data for speciality Products
• Ensure that all submissions and correspondences are documented and archived as per established procedure and distribute it within the Global Regulatory team and any other external stakeholders that is directly affected by the communication
• Ensure adherence to submission timelines
• Lead quality reviews including XML, hyperlinks, bookmarks, metadata, PDF compliance, and validation checks & ensure compliance with ICH eCTD specifications and regional regulatory submission requirement
• Ensure timely submission dispatch through FDA ESG, EMA Gateway, CESP, Health Canada, MHRA, GCC, and other Health Authority portals

1. Regulatory Information Management & Data Standardization

• Oversee the implementation and optimization of Amplexor RIM and DMS systems supporting end-to-end regulatory processes.
• Drive data standardization initiatives enabling automated reporting, metrics visualization, and global transparency dashboards.

1. Systems, Technology & Innovation

• Lead the digital transformation roadmap for Regulatory Operations, focusing on automation, structured authoring, and analytics-based decision-making.

• Support new technology development within our Company

1. People Leadership & Stakeholder Management

• Build and mentor a high-performing global team of regulatory operations, publishing, and labelling professionals.