The pharmaceutical regulatory landscape is evolving rapidly, and Regulatory Affairs (Publishing) professionals are more critical than ever. If you have hands-on experience with eCTD submissions and USFDA regulations, an exciting career opportunity awaits you at Avet Life Sciences Ltd, Pune.
Avet Life Sciences is currently hiring experienced Regulatory Affairs Publishing professionals for an urgent opening at its Wakad, Pune facility.
About the Role: Regulatory Affairs (Publishing)
Regulatory Publishing is the final and most crucial step in global drug submissions. It ensures that regulatory dossiers are technically sound, compliant, and successfully transmitted to health authorities.
As part of the Regulatory Affairs Publishing team, you will play a key role in transforming scientific data into submission-ready regulatory applications for highly regulated markets like the United States.
Job Details at a Glance
- Position: Regulatory Affairs – Publishing
- Location: Wakad, Pune (Onsite)
- Experience Required: 3 to 7 Years
- Department: Regulatory Affairs
- Industry: Pharmaceuticals / Generic Drugs
Key Responsibilities
📑 eCTD Publishing
- Assemble, compile, and publish eCTD submissions
- Ensure compliance with global regulatory standards
⌨️ Document Formatting & OCR
- Format regulatory documents across all CTD modules
- Apply OCR to scanned documents for compliance and searchability
🇺🇸 USFDA Submissions
- Handle submissions in line with USFDA electronic submission guidelines
- Manage lifecycle activities for ANDA, NDA, DMF, and related filings
📊 Regulatory Data Management
- Track submission sequences and metadata
- Maintain accurate archival and retrieval of regulatory data
Required Qualifications
🎓 Education
- B.Pharm or M.Pharm (Mandatory)
💼 Experience
- 3–7 years of hands-on experience in Regulatory Affairs Publishing
🛠️ Technical Skills
- Strong expertise in:
- eCTD publishing and validation tools
- Adobe Acrobat Professional
- XML-based submission systems
Why Join Avet Life Sciences?
✨ Career Growth
Work on complex global submissions that enhance your technical and regulatory expertise.
📍 Prime Pune Location
The Wakad office is located in Pune’s fast-growing biotech and IT corridor with excellent connectivity.
🌍 Global Impact
Your work directly supports drug approvals in some of the world’s most stringent regulatory markets.
How to Apply (Urgent Hiring)
Interested candidates are encouraged to apply immediately as interviews will be conducted on a priority basis.
📧 Send your CV to:
deepsingh.dhalwale@avetlifesciences.com
👤 Contact Person: Deepsingh Dhalwale
📌 Email Subject Line:
Application for RA Publishing – [Your Name] – [Years of Experience]
Important:
Ensure your CV clearly mentions:
- Publishing tools used
- Types of US submissions handled (ANDA, NDA, DMF, etc.)
Final Thoughts
Regulatory Affairs Publishing is a highly specialized and in-demand domain. Professionals with 3–7 years of experience are perfectly positioned for long-term growth, leadership roles, or global regulatory exposure.
If you are based in Pune—or open to relocating to Wakad—this opportunity at Avet Life Sciences could be a significant step forward in your regulatory career.
