PHARMAFull-time
Senior Executive - Regulatory Affairs
By Admin · Regulatory Affairs
TANDALJA (IN)ONSITEPOSTED: 8/31/2026
PHARMAFull-time
HIRING ORGANIZATIONSUN PHARMACEUTICAL INDUSTRIES LTDPharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Review all technical data and documentation required for drug product registrations across international health authorities.
Compile and format comprehensive registration dossiers for submission to global regulatory agencies including US-FDA, Health Canada, Europe (EMA), Australia/New Zealand (TGA/Medsafe), Japan (PMDA), and Israel.
Prepare, review, and submit timely scientific advice and responses to regulatory deficiency letters received from global health authorities.
Maintain lifecycle management and compile post-approval changes for drug product registration dossiers.
Execute eCTD compilation, quality verification, and electronic submission through authorized regulatory gateways.
Review, prepare, and submit Annual Reports and post-approval supplements to the US FDA.
Technical & Domain Standards
Maintain strict regulatory compliance with international submission standards (US-FDA, Health Canada, EMA, TGA, PMDA).
Utilize eCTD publishing software and electronic gateway portals for dossier submissions while providing regulatory support to cross-functional R&D departments.
Leadership & Impact
Drive lifecycle management efficiency for global product portfolios while ensuring flawless regulatory compliance and business continuity.
Collaborate with cross-functional R&D and manufacturing teams to resolve regulatory queries rapidly.
Benefits & Total Rewards
Full-time career opportunity within Sun Pharma's premier R&D unit with comprehensive corporate benefits and professional growth support.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
Dossier Compilation
US-FDA
Health Canada
EMA
eCTD Publishing
Deficiency Responses
Post-Approval Supplements
Annual Reports
M.Pharm
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Competitive pharmaceutical industry salary package for 1-5 years of regulatory affairs experience in India, supplemented by performance bonuses, corporate healthcare benefits, and career development programs.
ORGANIZATION CONTEXT & CULTURE
Sun Pharmaceutical Industries Ltd is actively hiring for this position.
INDUSTRY: Pharmaceuticals
EXPECTED CAREER ROADMAP
This role offers a structured career advancement pathway at Sun Pharma, allowing early-career regulatory professionals to progress into Lead Executive, Manager, or Global Regulatory Strategy Lead positions across regulated international markets.
APPLICATION ADVISORY
Candidates should highlight hands-on experience in compiling eCTD dossiers for US-FDA or European markets, detail familiarity with post-approval supplements, and emphasize strong M.Pharm academic credentials.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.