Laxaura is inviting applications from qualified pharmaceutical professionals for the position of Regulatory Affairs (RA) Executive at its Ahmedabad facility. This opportunity is ideal for B.Pharmacy graduates with 1-2 years of pharmaceutical industry experience who are looking to build a rewarding career in regulatory affairs, dossier preparation, CTD documentation, and pharmaceutical compliance.
The company is seeking detail-oriented candidates with expertise in regulatory documentation, process validation, stability data management, artwork review, and pharmaceutical dossier compilation. Candidates with hands-on experience in CTD/ACTD submissions and regulatory compliance processes are encouraged to apply.
Job Overview
| Particulars | Details |
|---|---|
| Position | Regulatory Affairs Executive |
| Department | Regulatory Affairs (RA) |
| Company | Laxaura |
| Location | Gota, Ahmedabad, Gujarat |
| Qualification | B.Pharmacy |
| Experience | 1-2 Years |
| Gender Preference | Female Candidates Only |
| Industry | Pharmaceutical |
| Employment Type | Full-Time |
Key Responsibilities
The selected Regulatory Affairs Executive will be responsible for:
- Preparation and review of CTD and ACTD dossiers.
- Handling Modules 1 to 5 for regulatory submissions.
- Preparation and management of Process Validation (PV) documentation.
- Stability data compilation and regulatory review.
- Product Development Reports (PDR) preparation.
- Artwork checking and compliance verification.
- Preparation of BMR (Batch Manufacturing Record) and BPR (Batch Packaging Record).
- Drafting and reviewing SMPC documents.
- Leaflet and package insert preparation.
- AMV documentation management.
- CDP matching and compliance verification.
- Preparation and review of Specifications, COA, and MOA documents.
- Final product specification documentation.
- Self-review and regulatory compliance verification of documents.
Required Skills
Candidates applying for this Regulatory Affairs Executive job should possess:
- Strong understanding of CTD/ACTD dossier preparation.
- Knowledge of pharmaceutical regulatory requirements.
- Experience with Process Validation and Stability documentation.
- Expertise in BMR/BPR preparation.
- Regulatory artwork review skills.
- Documentation and compliance management capabilities.
- Good communication and analytical skills.
- Attention to detail and accuracy in regulatory submissions.
Educational Qualification
Mandatory Qualification
- Bachelor of Pharmacy (B.Pharm)
Preferred Profile
- Candidates with 1-2 years of Regulatory Affairs experience in the pharmaceutical industry.
- Knowledge of international regulatory documentation standards.
- Experience handling pharmaceutical registration dossiers.
Why Join Laxaura?
Laxaura offers professionals an opportunity to work in a quality-driven and compliance-focused pharmaceutical environment. Employees gain exposure to:
- Regulatory submissions and dossier management.
- Global pharmaceutical documentation practices.
- Cross-functional collaboration with quality and production teams.
- Career growth within the Regulatory Affairs domain.
- Professional development in pharmaceutical compliance and registration activities.
Salary and Benefits
Based on industry standards for Regulatory Affairs Executive roles in Ahmedabad, the expected salary range is:
₹3.2 LPA – ₹5.5 LPA
Actual compensation may vary depending on candidate experience, skills, and company policies.
How to Apply
Interested and eligible candidates can send their updated resume to:
📧 Email: recruitment@laxaurabusiness.com