Aurobindo Pharma Limited has announced exciting career opportunities for experienced Regulatory Affairs (RA) professionals in its US Market and EU Market divisions. Candidates with relevant Regulatory Affairs experience and B.Pharm/M.Pharm qualifications are invited to apply for these positions at the company’s Hyderabad facility.

If you have expertise in ANDA filing, CMC, Post Approvals, Lifecycle Management (LCM), or Regulatory Affairs, this is an excellent opportunity to build your career with one of India’s leading pharmaceutical companies.

Company Details

Company Name: Aurobindo Pharma Ltd.

Department: Regulatory Affairs

Job Type: Full-Time

Work Location: APLRC-1, Hyderabad

Industry: Pharmaceutical

Application Mode: Email

Available Positions

1. US Market – Regulatory Affairs

Requirements

RAD-US – ANDA Filing

RAD-US – SPD (Topical/Derma)

Experience

4.5 to 6 years in Regulatory Affairs (US Market)

Qualification

B.Pharm / M.Pharm

Specialization:

Regulatory Affairs

Pharmaceutics

2. EU Market – Regulatory Affairs

Requirements

RA EU – Pre & Post Approvals

RA EU – CMC (Lifecycle Management)

Experience

2 to 5 years in EU CMC – Post Approvals

8 to 12 years in EU CMC – LCM

Qualification

M.Pharm

Preferred Specialization:

Regulatory Affairs

Pharmaceutics

Pharmaceutical Analysis

Quality Assurance

Job Location

APLRC-1, Hyderabad

How to Apply

Interested and eligible candidates can send their updated CV to the appropriate email address based on the market they are applying for.

US Market

Email: Sreeja.Yangam@aurobindo.com

EU Market

Email: Pooja.Uppalapati@aurobindo.com

Skills Required

Regulatory Affairs documentation

ANDA filing knowledge

CMC documentation

Lifecycle Management (LCM)

Post Approval submissions

EU & US regulatory guidelines

Pharmaceutical documentation

GMP & ICH guideline awareness

Strong communication skills

Documentation review and compliance

Why Join Aurobindo Pharma?

One of India’s leading global pharmaceutical companies.

Opportunity to work on regulated international markets.

Exposure to USFDA and European regulatory submissions.

Career growth in Regulatory Affairs.

Professional work environment with advanced R&D facilities.

Important Note

Read the eligibility criteria carefully before applying.

Mention the position and market (US/EU) in the email subject line.

Keep your resume updated with relevant Regulatory Affairs experience.

Technical FAQs

1. What is ANDA filing in the US pharmaceutical market?

An Abbreviated New Drug Application (ANDA) is submitted to the USFDA for approval to market generic drugs by demonstrating bioequivalence to the reference listed drug without repeating full clinical trials.

2. What is CMC in Regulatory Affairs?

CMC (Chemistry, Manufacturing and Controls) includes detailed information about drug composition, manufacturing process, quality control, stability data, packaging, and specifications required for regulatory approval.

3. What is Lifecycle Management (LCM)?

Lifecycle Management involves managing approved pharmaceutical products through post-approval changes, renewals, variations, label updates, manufacturing changes, and continuous regulatory compliance.

4. What are Post Approval submissions?

Post Approval submissions are regulatory filings made after product approval to report manufacturing changes, process improvements, site transfers, labeling updates, or other variations required by health authorities.

5. Which regulatory guidelines should Regulatory Affairs professionals know?

Candidates should have knowledge of:

USFDA regulations

EMA guidelines

ICH Guidelines (Q, E, M series)

eCTD submission process

GMP requirements

Pharmaceutical quality documentation