PHARMAFull-time
Regulatory Affairs – Executive / Trainee
By Admin · Regulatory Affairs
CHENNAI (IN)ONSITEPOSTED: 10/8/2026
PHARMAFull-time
HIRING ORGANIZATIONAXXELENT PHARMA SCIENCE PRIVATE LIMITEDPharmaceuticals
ROLE OVERVIEW
Axxelent Pharma Science Private Limited is recruiting entry-level candidates for a Regulatory Affairs Executive / Trainee position based in Tharamani, Chennai. The role involves preparing dossier packages, formatting CTD / eCTD documents, and handling regulatory compliance workflows.
ROLE DEFINITION & RESPONSIBILITIES
- •Assist in preparing, formatting, and assembling regulatory submission dossiers
- •Organize and compile records matching CTD and eCTD specifications
- •Liaise with internal research, quality, and formulation teams to gather required technical documentation
- •Monitor submission progression, manage audit logs, and maintain regulatory databases
- •Review technical documents to confirm consistency, completeness, and regulatory alignment
- •Help draft formal responses to health authority queries under senior guidance
- •Support documentation for post-approval variations, renewals, and lifecycle changes
- •Maintain document control, version tracking, and strict technical confidentiality
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master of Pharmacy (M.Pharm)
- 0 to 1 year of experience in regulatory affairs, submissions, or pharmaceutical R&D
PREFERRED QUALIFICATIONS
- •Basic understanding of CTD / eCTD dossier formatting
- •Familiarity with ICH guidelines and global agency frameworks such as USFDA, EMA, MHRA, and WHO
- •Knowledge of GMP and pharmaceutical development systems
- •Competence in Microsoft Word and Microsoft Excel
REQUIRED VERIFIED SKILLS
Technical writing
Document control
Cross-functional coordination
Attention to detail
Microsoft Office
COMPENSATION & REWARDS
₹2.4L - 2.6L per annum
Benefits: Food provided, Provident Fund, Flexible schedule
The position offers an annual pay range of INR 2,40,000 to INR 2,60,000.
ORGANIZATION CONTEXT & CULTURE
Axxelent Pharma Science Private Limited is a research-oriented pharmaceutical company focused on delivering compliant solutions to global healthcare markets.
INDUSTRY: Pharmaceuticals
EXPECTED CAREER ROADMAP
The role offers professional growth in global regulatory submissions, CTD/eCTD dossier management, product registration, and health authority correspondence.
APPLICATION ADVISORY
Emphasize your M.Pharm specialization and any academic projects or coursework touching on CTD/eCTD dossier compilation and ICH guidelines. Detail your proficiency with MS Word formatting and document management.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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