Manager - Regulatory Operations & Publishing

Job Title: Sr. Manager - Regulatory Operations & Publishing

Business Unit: Regulatory & Business Continuity

Job Grade: G9

Location: Gurgaon

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

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.

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

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 labelling 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 have an impact on product development to assess approval pathways and associated risks
• Participate in authoring and/or reviewing of the departmental procedure/guidance as applicable
• Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply generic products worldwide

Qualification, Skill and Competencies Requirements

• At least 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 in a succinct and logical manner.
• Strong 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.