PHARMAFull-time
Senior Executive - RA
By Admin · Regulatory Affairs
BARODA (IN)ONSITEPOSTED: 8/28/2026
PHARMAFull-time
HIRING ORGANIZATIONSUN PHARMACEUTICAL INDUSTRIES LTDPharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Review data and documentation associated with product registrations for submission to various health authorities.
Compile regulatory registration dossiers for multiple international markets, including US FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.
Prepare responses to deficiency letters and questions received from regulatory agencies.
Manage lifecycle and post-approval changes for drug-product registration dossiers.
Provide regulatory support to cross-functional departments involved in product development and registration activities.
Prepare and submit requests for scientific advice to relevant health authorities.
Perform eCTD compilation, verification, and submission through electronic gateways.
Review, prepare, and submit annual reports to the US FDA.
Review, prepare, and submit post-approval supplements to the US FDA.
Regulatory & Technical Expertise
International pharmaceutical regulatory submissions and product registration.
Regulatory dossier compilation and lifecycle management.
Deficiency-letter response preparation.
Post-approval regulatory change management.
eCTD compilation, verification, and electronic submission.
US FDA annual-report and post-approval supplement submissions.
Scientific-advice preparation and regulatory authority interaction.
Regulatory support across cross-functional R&D activities.
Educational Qualification & Experience
M. Pharm qualification required.
Required experience: 4-8 years.
Job grade: G11B, Senior Executive.
Business Unit: R&D1 Regulatory Affairs.
Job function/title area: Regulatory and Business Continuity.
Location: Tandalja R&D / Baroda.
Travel estimate: Not applicable (NA).
Cross-Functional & Business Impact
Support successful product registrations across major global regulatory markets.
Help maintain regulatory compliance throughout the product lifecycle and after approval.
Coordinate regulatory activities with cross-functional teams to support timely submissions and responses.
Contribute to regulatory strategies involving scientific advice, deficiency responses, eCTD submissions, annual reports, and post-approval supplements.
Company & Career Environment
Sun Pharma describes its culture around continuous improvement, self-drive, ownership, confidence, and collaboration.
The company emphasizes employee growth, professional development, collaboration, and opportunities to make a lasting impact.
Sun Pharma states that employee success and well-being are supported through benefits and professional-growth opportunities.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
M. Pharm
Product Registration
Regulatory Dossiers
US FDA
Health Canada
Europe
Australia/New Zealand
Japan
Israel
Deficiency Responses
Lifecycle Management
Post-Approval Changes
Scientific Advice
eCTD
Electronic Submissions
US FDA Annual Reports
US FDA Post-Approval Supplements
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Sun Pharmaceutical Industries Ltd is actively hiring for this position.
INDUSTRY: Pharmaceuticals
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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