Chemo India Formulation Pvt Ltd has announced exciting career opportunities for experienced professionals in the Regulatory Affairs department. Candidates with M.Pharm or B.Pharm qualifications and experience in US market OSD formulations are invited to apply for this latest pharmaceutical job opening in Hyderabad.
This pharma hiring opportunity is ideal for candidates searching for Regulatory Affairs jobs in Hyderabad, USFDA formulation jobs, OSD regulatory affairs careers, pharmaceutical regulatory jobs in Telangana, and pharma company vacancies for M.Pharm and B.Pharm candidates.
Job Details
| Department | Qualification | Experience |
|---|---|---|
| Regulatory Affairs | M.Pharm / B.Pharm | 4 to 5 Years |
Key Responsibilities
- Preparation, review, and submission of regulatory dossiers for US market formulations.
- Handling ANDA filing documentation and lifecycle management activities.
- Coordination with cross-functional departments including QA, QC, and Production.
- Compilation and review of CTD/eCTD submissions.
- Managing regulatory compliance for OSD pharmaceutical products.
- Addressing deficiency responses and regulatory queries.
- Maintaining regulatory documentation as per USFDA guidelines.
- Tracking submission timelines and approvals.
Required Qualifications & Skills
- M.Pharm or B.Pharm qualification from a recognized university.
- 4 to 5 years of experience in Regulatory Affairs for US market formulations.
- Strong understanding of OSD formulation regulatory requirements.
- Experience in ANDA submissions and eCTD compilation.
- Knowledge of USFDA regulatory guidelines and documentation practices.
- Excellent communication and documentation skills.
- Ability to work in a regulated pharmaceutical environment.
Job Location
Venue:
Chemo India Formulation Pvt Ltd
Gowra Fountainhead, HUDA Techno Enclave Road, Madhapur, Hyderabad, Telangana
Salary & Benefits
Expected Salary
- ₹5.5 LPA – ₹8.5 LPA (Expected industry-standard salary based on experience and skills)
Employee Benefits
- Opportunity to work with a globally recognized pharmaceutical organization.
- Exposure to US regulatory market submissions.
- Career growth in Regulatory Affairs and pharmaceutical compliance.
- Professional learning and development opportunities.
- Dynamic and collaborative work environment.
How to Apply
Interested and eligible candidates can share their updated CV to:Application for Regulatory Affairs Position
Application for Regulatory Affairs Position
jagadish.s@chemogroup.com
