Ahmedabad’s pharmaceutical industry continues to expand, creating strong demand for professionals in Regulatory Affairs, Labeling Compilation, and eCTD Publishing. Multiple openings are now available for B.Pharm, M.Pharm, and Life Sciences graduates, ranging from entry-level to experienced roles.
If you are aiming for a career in global regulatory submissions, labeling compliance, or USFDA-focused regulatory operations, this is a high-value opportunity to work across international markets including Europe, Canada, MENA, CIS, LATAM, and Asia.
🔹 Open Positions
1. Executive – Labeling Compilation (Freshers Eligible)
- Location: Ahmedabad
- Qualification: B.Sc, M.Sc, B.Pharm
- Experience: 0–2 Years
2. Senior Executive – Regulatory Affairs
- Location: Ahmedabad
- Qualification: M.Pharm
- Experience: Relevant regulatory experience required
3. Executive/Sr. Executive – Regulatory Operations (eCTD)
- Location: Ahmedabad
- Qualification: B.Pharm / M.Pharm
- Experience: 3–4 Years
🔹 Key Responsibilities
Labeling Compilation Role:
- Draft and format product labels, inserts, cartons, and leaflets
- Ensure compliance with global regulatory labeling guidelines
- Cross-check critical product information (drug name, strength, batch, expiry)
- Coordinate with Regulatory, QA, Medical, and Packaging teams
- Maintain labeling version control and approval records
- Support regulatory submissions with labeling documentation
- Ensure GMP compliance and SOP adherence
Regulatory Affairs Role:
- Handle ANDA submissions and post-approval changes
- Draft Annual Reports as per USFDA guidelines
- Review DMF and regulatory documentation
- Prepare CTD modules and FDA correspondence
- Manage submission timelines and cross-functional coordination
Regulatory Operations (eCTD):
- Prepare and publish eCTD submissions (ANDA/NDA)
- Manage Module 1 and submission metadata
- Perform validation checks and resolve publishing errors
- Handle lifecycle management (replace, append, delete sequences)
- Submit via ESG and track acknowledgements (ACK1/2/3)
- Ensure compliance with USFDA eCTD standards
🔹 Required Skills
- Strong knowledge of regulatory guidelines (ICH, USFDA)
- Attention to detail in labeling and documentation
- eCTD publishing tools and submission lifecycle knowledge
- Communication and cross-functional coordination
- Understanding of GMP and regulatory compliance
🔹 Benefits of These Roles
- Exposure to global regulatory markets
- Career growth in high-demand pharma domains
- Opportunity to work on USFDA and international submissions
- Skill development in labeling, CTD, and eCTD systems
🔹 How to Apply
Application Link For Executive – Labeling Compilation (Freshers Eligible)
Application Link For Senior Executive – Regulatory Affairs
Application Link For Executive/Sr. Executive – Regulatory Operations (eCTD)
