PHARMAFull-time
Executive - Regulatory Affairs
PANOLI (IN)ONSITEPOSTED: 9/22/2026
PHARMAFull-time
HIRING ORGANIZATIONSUN PHARMACEUTICAL INDUSTRIES LTDPharmaceuticals
ROLE OVERVIEW
Support plant and corporate Regulatory Affairs activities for global pharmaceutical submissions, GMP documentation and QMS coordination, with a focus on accurate compilation, review and timely execution of regulatory deliverables.
ROLE DEFINITION & RESPONSIBILITIES
- •Review and maintain GMP documents
- •Coordinate QMS activities including Change Control
- •Review and approve documents such as SOPs and STPs
- •Review, follow up and compile data for USDMF, CEP, DCP, CP and MRP submissions and amendments
- •Support USDMF and DMF amendment/update activities for corporate Regulatory Affairs locations
- •Compile data for regulatory submissions and amendments for Japan, China, TGA and Canadian markets
- •Compile raw data for registration, re-registration and regulatory authority queries across ROW markets
- •Coordinate plant Regulatory Affairs activities and timelines
Reporting Hierarchy: Reports within the R&D1 Regulatory Affairs organization and coordinates with plant and Corporate Regulatory Affairs teams; specific reporting manager and team size are not stated in the posting.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- M.Pharm or M.Sc
- 4-6 years of relevant Regulatory Affairs experience
- Knowledge of GMP documentation and QMS activities
- Experience with regulatory submission data compilation and document review
- Ability to coordinate regulatory activities against timelines
PREFERRED QUALIFICATIONS
- •Experience with DMF submissions and amendments
- •Exposure to CEP, DCP, CP and MRP submissions
- •Experience supporting global markets including US, Japan, China, TGA, Canada and ROW markets
- •Experience handling regulatory authority queries
REQUIRED VERIFIED SKILLS
Regulatory Affairs
GMP
QMS
Change Control
SOP
STP
USDMF
DMF
CEP
DCP
CP
MRP
regulatory submissions
DMF amendments
registration
re-registration
regulatory authority queries
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development, employee wellbeing support and opportunities for personal and professional growth; specific benefits are not detailed in the posting.
The posting does not disclose a salary range, bonus or equity package. Compensation should therefore be confirmed directly with Sun Pharmaceutical Industries Ltd during recruitment.
ORGANIZATION CONTEXT & CULTURE
Sun Pharmaceutical Industries Ltd is a global pharmaceutical company focused on developing, manufacturing and marketing medicines across multiple therapeutic areas and international markets.
TEAM SIZE: Large global pharmaceutical organization; exact employee count not stated in the posting
INDUSTRY: Pharmaceuticals
Culture: Sun Pharma highlights continuous improvement, self-drive, ownership, collaboration, professional growth and a supportive work environment.
EXPECTED CAREER ROADMAP
Potential progression may include Senior Executive or Manager-level Regulatory Affairs roles, with opportunities to specialize in DMF management, global submissions, CMC regulatory affairs or broader plant and corporate regulatory leadership.
APPLICATION ADVISORY
Emphasize 4-6 years of Regulatory Affairs experience and M.Pharm/M.Sc qualification; highlight GMP documentation and QMS experience; demonstrate hands-on exposure to DMF submissions and amendments; mention experience with US, EU or other international regulatory markets; highlight document review, data compilation and regulatory-query handling; demonstrate strong coordination and timeline-management skills.
RECOMMENDED TRAINING
1/5
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