Aculife Healthcare Pvt. Ltd. (Nirma Group) has announced an exciting opportunity for M.Pharm graduates seeking a career in Regulatory Affairs (RA). The company is hiring for the role of Trainee Officer – Regulatory Affairs at its Ahmedabad head office.
This is an excellent opportunity for freshers and early professionals with 6 months to 1 year of Regulatory Affairs experience, including internships or apprenticeships, to enter the pharmaceutical regulatory domain and work on global markets like LATAM and EU.
Job Overview
- Position: Trainee Officer – Regulatory Affairs
- Location: Ahmedabad, Gujarat
- Experience: 6 months to 1 year (RA internship/apprenticeship accepted)
- Qualification: M.Pharm (Regulatory Affairs / Pharmaceutics preferred)
- Industry: Pharmaceutical / Healthcare
Key Responsibilities
The selected candidate will be involved in core Regulatory Affairs operations, including:
- Compilation and review of registration dossiers as per country-specific guidelines
- Handling submissions for LATAM markets (Brazil, Mexico) and exposure to EU regulatory requirements
- Reviewing critical technical documents such as:
- Drug Master File (DMF)
- Product Development Report
- Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR)
- Analytical Method Validation Reports
- Stability Reports & BE Study Reports
- Preparing deficiency responses and managing backlog dossiers
- Supporting post-approval changes (variations) as per regulatory guidelines
- Coordination with global regulatory teams, agents, and distributors
- Reviewing artworks and packaging materials for product launches
- Maintaining and updating regulatory databases and submission records
Eligibility Criteria
To apply for this Regulatory Affairs job in Ahmedabad, candidates must meet the following criteria:
- M.Pharm degree (mandatory)
- 6–12 months experience in Regulatory Affairs (including internships)
- Basic knowledge of CTD/eCTD, DMF, and dossier compilation
- Understanding of global regulatory guidelines (EU, LATAM preferred)
- Strong attention to detail and documentation skills
Salary & Benefits
- Salary Range: ₹2.5 LPA – ₹4.5 LPA (Expected for trainee-level roles)
- Opportunity to work with a leading pharma company under Nirma Group
- Hands-on experience in international regulatory submissions
- Career growth in Regulatory Affairs domain
Why This Job is Important for Pharma Freshers
This role is highly relevant for candidates targeting careers in:
- Regulatory Affairs (RA)
- Pharmaceutical Documentation
- Global Submissions (EU, LATAM markets)
- Dossier Preparation & Lifecycle Management
With increasing demand for Regulatory Affairs professionals in India, this opportunity provides strong exposure to international compliance standards, making it ideal for long-term career growth.
How to Apply
Interested and eligible candidates can apply by sending their updated resume to:
Tip: Mention “Application for RA Trainee Officer – Ahmedabad” in the subject line to improve visibility.