Regulatory Affairs Openings at Aurobindo Pharma
- Regulatory Affairs Jobs Aurobindo Pharma | Hyderabad
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Aurobindo Pharma?
- FAQs
- Summary Table
Regulatory Affairs Jobs Aurobindo Pharma | Hyderabad
Apply for Aurobindo Pharma Regulatory Affairs roles for US, EU & Canada markets in Hyderabad. M.Pharm graduates with 3–10 years’ experience eligible.
Join Aurobindo Pharma, one of India’s largest and most respected pharmaceutical companies, as part of their Regulatory Affairs team in Bachupally, Hyderabad. If you are a regulatory professional with experience in CMC submissions, post-approval changes, and dossier preparation for global markets like the US, EU, and Canada, this opportunity offers a chance to grow your career in an organization known for innovation, integrity, and global impact.
Company Overview
Aurobindo Pharma Limited is a leading vertically integrated pharmaceutical company headquartered in Hyderabad, India. With operations spanning over 150 countries, Aurobindo specializes in generic formulations, active pharmaceutical ingredients (APIs), and biosimilars, consistently contributing to affordable global healthcare.
The company’s Regulatory Affairs division plays a crucial role in ensuring global compliance for product approvals, lifecycle management, and post-marketing submissions. Joining Aurobindo means contributing to a mission-driven organization focused on improving health worldwide through research, quality, and regulatory excellence.
Job Role & Responsibilities
Position: Regulatory Affairs – US, EU, and Canada Markets
Location: Bachupally, Hyderabad
Department: Regulatory Affairs – Formulations (Oral Solid Dosage)
Aurobindo Pharma seeks talented regulatory professionals for key markets. The selected candidates will manage regulatory documentation, submission processes, and lifecycle maintenance for global pharmaceutical products.
For US Market:
- Handle CMC (Module 2 & 3) submissions, post-approval supplements, and annual report submissions.
- Address and resolve regulatory queries efficiently.
- Manage change controls and support new drug product applications (NDA/ANDA).
For EU Market:
- Prepare and maintain administrative modules for DCP, RUP, and NP submissions.
- Support life cycle management activities and ensure compliance with EU regulatory frameworks.
- Collaborate with cross-functional teams for timely submission of variations and renewals.
For Canada Market:
- Compile and review Module 2 and 3 for Canadian submissions.
- Manage quality modules and review plant-related documents for accuracy and compliance.
- Support pre-approval inspections and post-approval commitments.
Eligibility / Qualifications
Educational Qualification:
- M.Pharm (Pharmaceutical Regulatory Affairs / Pharmaceutics / Pharmaceutical Analysis / Quality Assurance)
Experience Required:
- US Market: 6–10 years
- EU Market: 4–6 years
- Canada Market: 3–5 years
Key Skills:
- Expertise in CMC dossier preparation (Modules 2 & 3) and regulatory submissions.
- Strong understanding of ICH, USFDA, EMA, and Health Canada guidelines.
- Proven ability in post-approval management, variation filings, and query handling.
- Experience in formulation – OSD (Oral Solid Dosage) regulatory submissions.
Location & Salary
- Location: Bachupally, Hyderabad
- Mode of Work: Full-time (On-site)
- Salary: Competitive and commensurate with experience and industry standards
Application Process
Interested candidates with relevant regulatory affairs experience can apply by sharing their updated resumes with the subject line “Application – Regulatory Affairs” to:
📧 Sreeja.Yangam@aurobindo.com
⚠️ Apply early to secure your chance to be part of Aurobindo Pharma’s Global Regulatory Affairs team in Hyderabad.
Why Join Aurobindo Pharma?
- Work with a global pharmaceutical leader known for regulatory excellence and product innovation.
- Gain exposure to USFDA, EMA, and Health Canada submission processes.
- Build a rewarding career with cross-market regulatory exposure (US, EU & Canada).
- Collaborate with industry-leading experts and work on world-class formulations.
- Strong focus on professional growth, compliance, and continuous learning.
FAQs
1. What qualifications are required for Aurobindo Pharma’s Regulatory Affairs roles?
Candidates must hold an M.Pharm in Regulatory Affairs, Pharmaceutics, or Pharmaceutical Analysis.
2. What experience is needed for the US, EU, and Canada markets?
- US Market: 6–10 years
- EU Market: 4–6 years
- Canada Market: 3–5 years
3. Where is the position located?
The position is based in Bachupally, Hyderabad, at Aurobindo Pharma’s global headquarters.
4. How can I apply?
Email your resume to Sreeja.Yangam@aurobindo.com with the subject line “Application – Regulatory Affairs.”
5. What type of products will I work on?
You will handle regulatory documentation for Formulation – OSD (Oral Solid Dosage) products.
Summary Table
| Category | Details |
|---|---|
| Company | Aurobindo Pharma Limited |
| Department | Regulatory Affairs – Formulations (OSD) |
| Markets | US, EU, Canada |
| Location | Bachupally, Hyderabad |
| Education Required | M.Pharm (RA / Pharmaceutics / QA / Pharmaceutical Analysis) |
| Experience Required | US: 6–10 yrs |
| Responsibilities | CMC (M2 & M3), DCP, RUP, NP submissions, query handling, post-approvals |
| Contact Email | Sreeja.Yangam@aurobindo.com |
To apply for this job email your details to Sreeja.Yangam@aurobindo.com
