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Title: Sr. Manager - Regulatory Operations & Publishing
Date: Sep 19, 2026
Location: Gurgaon - R&D;
Company: Sun Pharmaceutical Industries Ltd

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 a regulatory operations perspective.
- Manages the regulatory submissions strategy and operational activities across global submission management, data archival, data security, data retrieval and management, using Amplexor's Regulatory Information Management System (RIMS), etc.
- Provides strategic and regulatory operational direction for all generic products.
- Collaborates with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc., to ensure a smooth regulatory submission process.
- Manages end-to-end vendor management activities, formulates, develops, and executes a comprehensive regulatory submission strategy integrating regulatory requirements.
- Ensures global regulatory compliance, drives digital transformation, and implements data standardization initiatives to support seamless regulatory submissions.
- Forecasts operational activities and prepares in-house/outsourcing plans.
- Oversees hiring of new talent for the team.

Area Of ResponsibilityGlobal Regulatory Operations Leadership

- Lead global regulatory operations teams responsible for submission management, publishing, labeling, 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 process improvement initiatives such as digital automation and AI-enabled tools to improve operational efficiency and quality.

Publishing and Submission Management

- Oversee publishing activity (eCTD and Non-eCTD),



review, validate, and dispatch the submission across the globe as per the requirements of respective health agencies.
- Manage the 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 requirements for all generic products.
- Oversee the archival, maintenance, and security measures of all data for specialty products.
- Ensure that all submissions and correspondences are documented and archived as per established procedures and distributed within the Global Regulatory team and any other external stakeholders 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 requirements.
- Ensure timely submission dispatch through FDA ESG, EMA Gateway, CESP, Health Canada, MHRA, GCC, and other Health Authority portals.

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.

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.

People Leadership & Stakeholder Management

- Build and mentor a high-performing global team of regulatory operations, publishing, and labeling professionals.
- Foster a culture of accountability, innovation, and collaboration across regional hubs.




- Manage strategic partnerships with CROs, technology vendors, and publishing partners ensuring adherence to SLAs and KPIs.
- Represent Regulatory Operations in leadership forums, audits, and GRA governance meetings.
- Conduct department-level training, as necessary, to educate subordinates in the department on regulatory requirements, policies, and procedures.

Additional Responsibilities

- Support leadership team in compliance activities like Corporate Merger, Product transfer (in-license/out-license), etc.
- Socialize, execute, and maintain the regulatory commitments and requirements for assigned assets.
- Retain contemporary knowledge of regulations, directives, guidelines, and policies that may impact product development to assess approval pathways and associated risks.
- Participate in authoring and/or reviewing of departmental procedures/guidance as applicable.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and continued market supply of generic products worldwide.

Qualification, Skill and Competencies Requirements

- At least a Master's degree preferred, additional qualification in regulatory data management is desirable.
- Minimum of 15+ years of hands-on experience within Regulatory Operations & Submission management industry experience for Innovative portfolio.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues succinctly and logically.
- Solid listening skills.
- This role needs a seasoned professional who is aware of the regulatory activities for NDAs, CFT, and who has the management capability of leading a group of team members.
- The candidate must be proficient in English, spoken and written.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal, and negotiating skills.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and

📌 Title: Sr. Manager - Regulatory Operations & Publishing (Gurugram)
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