Axxelent Pharma Science Pvt Ltd is inviting applications for the position of Regulatory Affairs Executive / Trainee in Tharamani, Chennai. Candidates with an M.Pharm qualification and 0–1 year of experience, including freshers, can apply for this full-time, on-site opportunity.
The role focuses on regulatory documentation, CTD/eCTD dossier preparation, regulatory submissions, and pharmaceutical product lifecycle management.
Job Details
| Particulars | Details |
|---|---|
| Company | Axxelent Pharma Science Pvt Ltd |
| Job Title | Regulatory Affairs Executive / Trainee |
| Location | Tharamani, Chennai, India |
| Job Type | Full-Time |
| Work Mode | On-site |
| Qualification | M.Pharm |
| Experience | 0–1 Year |
| Salary | ₹2.4–2.6 LPA |
| Benefits | Provident Fund (PF), Flexible Work Schedule |
Positions Available
- Regulatory Affairs Executive
- Regulatory Affairs Trainee
Job Responsibilities
Selected candidates will support regulatory affairs activities, including:
- Preparing, formatting, and compiling regulatory submission dossiers.
- Organizing documentation according to CTD/eCTD requirements.
- Coordinating with R&D, Quality, and Formulation teams.
- Reviewing technical documents for accuracy, completeness, and consistency.
- Monitoring regulatory submissions and maintaining document records and audit trails.
- Supporting responses to health authority queries under senior guidance.
- Assisting with post-approval variations, renewals, and product lifecycle management.
- Maintaining document control, version tracking, and confidentiality.
Eligibility Criteria and Qualifications
Candidates interested in the Axxelent Pharma Science Regulatory Affairs recruitment must meet the following criteria:
- Educational Qualification: M.Pharm.
- Experience: 0–1 year.
- Freshers: Eligible to apply.
- Job Location: Tharamani, Chennai.
- Work Mode: On-site.
Required Skills
Applicants should have the following skills and knowledge:
- Technical writing and regulatory documentation.
- Document control and version management.
- Cross-functional coordination.
- Attention to detail.
- Microsoft Word and Excel.
- Basic knowledge of CTD/eCTD and ICH guidelines.
Salary and Benefits
- Salary: ₹2.4–2.6 LPA.
- Provident Fund (PF).
- Flexible work schedule.
How to Apply
Eligible candidates can submit their updated resumes through email using either of the following addresses:
- Email 1: corphr@axxelent.com
- Email 2: vrpradeep@axxelent.com