Aurobindo Hiring Regulatory Affairs

Aurobindo Pharma Regulatory Affairs Jobs 2026 – US Market ANDA Roles Hiring Now

Aurobindo Pharma is actively hiring experienced professionals for Regulatory Affairs roles focused on the US market, offering excellent career opportunities for candidates with 3 to 10 years of experience in ANDA filing, lifecycle management, and post-approval submissions. These roles are ideal for M.Pharm graduates aiming to build a strong career in global regulatory affairs within formulation and specialty dosage segments such as OSD, topical, nasal, and dermatological products.

This hiring drive is a valuable opportunity for professionals looking to work in highly regulated markets like the US FDA environment, where expertise in ANDA submissions and regulatory compliance plays a critical role in bringing safe and effective medicines to patients worldwide.

Company Overview

Aurobindo Pharma is one of India’s leading pharmaceutical companies with a strong global presence across more than 150 countries. The company is widely recognized for its leadership in generic pharmaceuticals, active pharmaceutical ingredients (APIs), and specialty products.

With a significant footprint in regulated markets like the United States and Europe, Aurobindo Pharma maintains strict compliance with global regulatory standards including USFDA, EMA, and ICH guidelines. The organization is known for its robust R&D capabilities, large-scale manufacturing infrastructure, and consistent focus on quality and innovation.

Working at Aurobindo Pharma provides:

• Exposure to global regulatory submissions and USFDA requirements
• Hands-on experience with ANDA filings and lifecycle management
• Opportunities to work on complex dosage forms like OSD, topical, and nasal products
• Strong career growth in regulatory affairs and pharmaceutical compliance

Job Role & Responsibilities

Regulatory Affairs – US Market

• Prepare and submit ANDA filings for Oral Solid Dosage (OSD) formulations
• Handle post-approval submissions, annual reports, and lifecycle management (LCM)
• Manage regulatory submissions for topical, nasal, and dermatological products
• Ensure compliance with USFDA, ICH, and global regulatory guidelines
• Coordinate with cross-functional teams including R&D, QA, and production
• Review and compile regulatory documentation for accuracy and completeness

These responsibilities are critical for ensuring regulatory approvals, maintaining product compliance, and supporting global pharmaceutical product launches.

Eligibility / Qualifications

Required Education

M.Pharm

Relevant Courses

Pharmaceutics, Regulatory Affairs, Pharmaceutical Analysis, Industrial Pharmacy

Experience

• 3 to 10 years of experience in regulatory affairs

Skills Required

• Strong knowledge of ANDA filing and USFDA regulatory requirements
• Experience in post-approval submissions and lifecycle management
• Understanding of OSD, topical, nasal, and dermatological products
• Excellent documentation and regulatory writing skills

Location & Salary

Job Location:

• Not explicitly mentioned (likely Hyderabad based on Aurobindo operations)

Salary:

• Competitive and based on experience and expertise

Application Process

Interested candidates can apply by sending their updated resume to:

• Email: sreeja.yangam@aurobindo.com

Ensure your profile highlights relevant regulatory affairs experience, especially in ANDA filings and US market exposure.

Why This Opportunity Matters

• Work with one of India’s top pharmaceutical exporters
• Gain exposure to USFDA regulatory submissions and approvals
• Build expertise in ANDA filing and lifecycle management
• Advance your career in global regulatory affairs

FAQs

Who can apply for this role?

Candidates with M.Pharm qualification and relevant regulatory affairs experience.

What experience is required?

3 to 10 years in ANDA filing and US market regulatory activities.

What type of products will I work on?

OSD, topical, nasal, and dermatological products.

How can I apply?

Send your updated resume to the provided email ID.

Is USFDA experience required?

Yes, hands-on experience with USFDA submissions is essential.

Summary Table

Company	Aurobindo Pharma
Vacancies	Regulatory Affairs Executive / Manager Roles
Required Education	M.Pharm
Experience	3–10 years