RA Senior Specialist – Regulatory Affairs
Requisition Number: 207680
Location: Gurgaon, Haryana, India
Job Category: Regulatory Affairs
Date Posted: September 4, 2026
Role Overview
As a Senior Regulatory Affairs Specialist, the position is responsible for the execution and maintenance of Regulatory Affairs activities for Baxter’s pharmaceutical and medical device product portfolios in India, while providing regulatory support for Bangladesh and Sri Lanka with limited supervision.
The role focuses on product registrations, lifecycle management, renewals, variations, regulatory submissions, health authority interactions, compliance activities, and maintaining continued market access.
Key Responsibilities
Regulatory Submissions and Product Registrations
Prepare and execute regulatory submissions, renewals, variations, and lifecycle management activities for assigned pharmaceutical and medical device portfolios in India.
Support regulatory activities for Bangladesh and Sri Lanka.
Compile, review, and submit regulatory dossiers, authority responses, and supporting documentation in accordance with local regulatory requirements and established timelines.
Support product registrations and regulatory approvals with Indian health authorities.
Manage medical device, pharmaceutical, import, and registration applications through applicable regulatory systems and portals, including SUGAM.
Support regulatory queries, authority interactions, approvals, and post-approval activities.
Lifecycle Management and Regulatory Compliance
Maintain product registrations and regulatory approvals by ensuring timely completion of:
Renewals
Post-approval changes
Regulatory commitments
Notifications
Lifecycle management activities
Perform regulatory assessments for changes related to:
Products
Manufacturing processes
Labeling
Artwork
Suppliers
Manufacturing and operating sites
Determine regulatory impact, reporting requirements, and appropriate submission strategies for proposed changes.
Ensure continued compliance with applicable regulatory requirements and company procedures.
Health Authority and External Stakeholder Interaction
Liaise with health authorities, distributors, license holders, and external regulatory partners.
Support product registrations, regulatory approvals, regulatory queries, and compliance activities.
Respond to health authority questions and requests for additional information.
Support regulatory interactions and maintain effective communication with relevant external stakeholders.
Coordinate with distributors and regulatory partners across South Asia where required.
Regulatory Intelligence
Monitor changes in regulatory requirements, guidelines, and regulatory expectations.
Track relevant regulatory intelligence and industry trends.
Assess potential regulatory risks and business impacts arising from changes in regulations.
Communicate relevant regulatory updates, requirements, risks, and opportunities to internal stakeholders.
Support implementation of regulatory changes within applicable product portfolios.
Labeling, Artwork, and Promotional Materials
Review and support approval of product labeling and artwork.
Review promotional materials and regulatory documentation for compliance with applicable local regulations and Baxter requirements.
Ensure product information remains aligned with approved regulatory requirements.
Support regulatory assessment and approval of labeling-related changes.
Inspections, Audits, Recalls, and Compliance Activities
Support health authority inspections and regulatory audits.
Assist with product recalls and related regulatory activities.
Support responses to regulatory observations, queries, commitments, and corrective actions.
Collaborate with cross-functional stakeholders to ensure regulatory commitments are completed within established timelines.
Identify potential compliance risks and escalate issues when appropriate.
Cross-Functional Collaboration
Work closely with:
Regulatory Affairs
Quality
Commercial
Supply Chain
Marketing
Medical Affairs
Global Regulatory Affairs
Distributors
External regulatory partners
Support product launches and market access activities.
Collaborate on lifecycle management and regulatory compliance initiatives.
Support supply continuity by addressing regulatory requirements that may affect product availability.
Coordinate multiple stakeholders to achieve regulatory and business objectives.
Work effectively within a matrix and multicultural organization.
Project and Stakeholder Management
Manage multiple regulatory activities simultaneously while meeting established timelines.
Plan and coordinate regulatory deliverables for assigned products and projects.
Demonstrate strong communication, coordination, negotiation, and stakeholder management skills.
Identify regulatory and compliance risks and escalate issues when necessary.
Maintain effective relationships with internal and external stakeholders.
Support business objectives while ensuring adherence to regulatory requirements.
Required Qualifications
Bachelor’s degree in one of the following or a related scientific discipline:
Pharmacy
Life Sciences
Biomedical Sciences
Biotechnology
Chemistry
Regulatory Affairs
Minimum 5 years of Regulatory Affairs experience within one or more of the following industries:
Pharmaceutical
Medical Devices
Biologics
Nutrition
Healthcare
Required Regulatory Experience
Experience with product registrations and regulatory submissions.
Experience with regulatory lifecycle management.
Experience with regulatory assessments and change management.
Experience interacting with health authorities.
Strong knowledge of Indian regulatory requirements.
Knowledge of South Asian regulatory requirements is preferred.
Knowledge of CDSCO regulations and regulatory processes.
Experience with SUGAM submissions and applicable regulatory portals.
Experience with regulatory intelligence and compliance activities.
Experience supporting post-approval regulatory activities.
Preferred Experience
Experience supporting regulatory activities across India and South Asia.
Experience working with distributors, license holders, or external regulatory partners.
Experience with pharmaceutical and/or medical device product portfolios.
Experience supporting product launches, lifecycle management, and market access activities.
Experience using Regulatory Information Management Systems (RIMS).
Experience with TrackWise.
Experience using SUGAM and other regulatory management tools.
Core Competencies
Regulatory Affairs expertise
Product registration and lifecycle management
Regulatory submission preparation
Health authority interaction
Regulatory assessment and change management
Regulatory intelligence
Compliance management
Project management
Stakeholder management
Communication and negotiation
Cross-functional collaboration
Risk identification and escalation
Ability to manage multiple priorities
Ability to work independently with limited supervision
Ability to work effectively in a matrix and multicultural environment
Geographical Scope
The primary regulatory responsibility is for India, with additional support for:
Bangladesh
Sri Lanka
The role therefore requires an understanding of India’s regulatory environment and the ability to support regulatory activities across South Asian markets.
Key Regulatory Areas
The position covers regulatory activities associated with:
Pharmaceutical products
Medical devices
Product registrations
Import applications
Renewals
Variations
Post-approval changes
Lifecycle management
Labeling and artwork
Regulatory submissions
Health authority queries
Regulatory commitments
Product recalls
Regulatory audits and inspections
Compliance activities
Market access
Regulatory intelligence
Equal Employment Opportunity
Baxter is an equal opportunity employer. Qualified applicants are considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability or handicap status, or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to individuals with disabilities globally. Candidates requiring an accommodation during any part of the application or interview process may contact Baxter through the accommodation process provided in the original job posting.
Recruitment Fraud Notice
Baxter has identified incidents of employment scams in which fraudulent individuals impersonate Baxter employees, recruiters, or other representatives to obtain personal or financial information.
Candidates should exercise caution when responding to recruitment communications and should refer to Baxter’s official Recruitment Fraud Notice for information on identifying and protecting themselves from employment-related scams.
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