A full-time Regulatory Affairs Associate – Trainee position is available in Bangalore for freshers and candidates with up to 1 year of experience. The role is part of the Regulatory Affairs department and provides hands-on training and mentorship in regulatory dossier submissions, document verification, health authority tracking, and regulatory compliance activities.
Candidates from Pharmacy, Biotechnology, Biochemistry, Life Sciences, or related STEM disciplines can apply.
Job Details
| Job Details | Information |
|---|---|
| Job Title | Regulatory Affairs Associate – Trainee |
| Department | Regulatory Affairs |
| Employment Type | Full-Time |
| Location | Bangalore |
| Experience | 0–1 Year |
| Eligible Candidates | Freshers, final-year students, recent graduates, and candidates with relevant internship experience |
| Application Email | bd@ipharmed.com |
Position
The Regulatory Affairs Associate – Trainee will support regulatory activities including CTD, eCTD, and ACTD dossier preparation, technical document review, regulatory guideline tracking, regulatory archiving, and preparation of responses to health authority inquiries.
The position offers structured mentorship and training from experienced regulatory managers.
Key Responsibilities
- Assist in drafting, compiling, and formatting regulatory dossiers such as CTD, eCTD, and ACTD for market authorization and renewal applications.
- Review technical documents, raw data, Batch Manufacturing Records (BMR), and analytical method validations for accuracy and regulatory compliance.
- Monitor regulatory guideline changes from authorities and organizations including FDA, EMA, CDSCO, and ICH.
- Communicate relevant regulatory updates to cross-functional teams.
- Coordinate with R&D, QC, QA, and supply chain teams to obtain technical information required for regulatory filings.
- Maintain regulatory databases and archive submitted dossiers, approval letters, regulatory commitments, and post-approval variations.
- Assist in drafting responses to inquiries and deficiency letters received from health authorities.
Eligibility & Qualifications
Candidates should meet the following requirements:
- Bachelor’s or master’s degree in Pharmacy, Biotechnology, Biochemistry, Life Sciences, or a related STEM field.
- 0–1 year of experience.
- Final-year students and recent graduates are encouraged to apply.
- Relevant internship experience is considered suitable.
- Formal certification or coursework in Regulatory Affairs or Drug Regulatory Affairs (DRA) is an advantage.
Required Skills
The role requires candidates who are:
- Detail-oriented
- Highly motivated
- Interested in Regulatory Affairs
- Able to review and manage technical documentation
- Interested in regulatory compliance and health authority requirements
- Able to coordinate with cross-functional teams
What the Role Offers
Selected candidates will receive:
- One-on-one training and mentorship from experienced regulatory managers.
- A career progression path from Associate Trainee to Regulatory Affairs Specialist.
- Support for relevant regulatory workshops, certifications, and industry seminars.
- A collaborative and innovation-driven work environment.
- Competitive entry-level salary.
- Health insurance.
- Paid leave.
- Annual performance bonuses.
Application Details
Interested candidates should submit their updated CV and a short cover letter explaining their interest in Regulatory Affairs.
Email: bd@ipharmed.com
Location: Bangalore
Experience: 0–1 Year
Employment Type: Full-Time