Aurobindo Hiring Regulatory Affairs

MPharm EU Regulatory Affairs Vacancies – Aurobindo Hyderabad

MPharm EU Regulatory Affairs vacancies at Aurobindo Pharma Hyderabad. 2–10 years experience, EU Module 2 & 3 roles.

Aurobindo Pharma Ltd is hiring experienced Regulatory Affairs professionals for its Formulation R&D division in Hyderabad. This opportunity is tailored for candidates with strong exposure to EU regulatory submissions who are eager to contribute to high-quality dossier preparation and lifecycle management for regulated European markets. The role offers direct involvement in EU filings, post-approval changes, and cross-functional regulatory coordination within a globally respected pharmaceutical organization.

Company Overview

Aurobindo Pharma Ltd is a globally recognized pharmaceutical company with operations spanning active pharmaceutical ingredients (APIs), formulations, and specialty products. The company supplies high-quality medicines to more than 150 countries and maintains a strong presence in regulated markets such as Europe and the United States.

Known for its regulatory strength and vertically integrated manufacturing capabilities, Aurobindo Pharma follows stringent EU-GMP, USFDA, and ICH guidelines. The organization’s Regulatory Affairs teams play a central role in enabling timely product approvals and ensuring uninterrupted patient access to affordable medicines worldwide.

Job Role & Responsibilities

Regulatory Affairs – Formulation R&D (EU Markets)

This role focuses on Chemistry, Manufacturing, and Controls (CMC) regulatory activities for European submissions.

Key Responsibilities:

• Preparation, compilation, and review of EU regulatory dossiers
• Authoring and reviewing Module 2 (Quality Overall Summary) and Module 3 (Quality)
• Interpretation and implementation of EU regulatory guidelines including EMA and ICH
• Handling post-approval variations and lifecycle management for EU markets
• Coordination with formulation R&D, QA, and manufacturing teams
• Review of plant-related and quality documents with a working understanding of QA systems
• Ensuring compliance with EU regulatory expectations and timelines

These responsibilities directly support successful product registrations and ongoing compliance in European markets.

Eligibility / Qualifications

Educational Qualification

MPharm

Relevant specializations include:

MPharm (Pharmaceutics), MPharm (Pharmaceutical Analysis), MPharm (Regulatory Affairs), MPharm (Quality Assurance)

Experience Requirement

• 2 to 10 years of Regulatory Affairs experience
• Mandatory hands-on experience with EU market submissions
• Strong working knowledge of Module 2 and Module 3 documentation

Location & Salary

Job Location

Hyderabad, Telangana

Salary details are not disclosed and will be offered based on experience, role fit, and interview performance, in line with industry standards.

Application Process

Interested candidates should send their updated resume via email.

Email ID: Pooja.Uppalapati@aurobindo.com

Email Subject Line: Application for EU Market

Candidates are encouraged to clearly highlight EU regulatory experience in their CV for faster shortlisting.

Why Build Your Regulatory Affairs Career with Aurobindo Pharma

• Work on EU regulatory submissions in a regulated global environment
• Exposure to complex CMC documentation and lifecycle management
• Strong regulatory science and compliance culture
• Collaboration with formulation R&D and quality teams
• Long-term growth in global regulatory affairs roles

Frequently Asked Questions (FAQs)

Who can apply for this Aurobindo Regulatory Affairs role?

MPharm professionals with EU Regulatory Affairs experience can apply.

Is EU market experience mandatory?

Yes. Hands-on experience with EU submissions is required.

What modules will the role focus on?

Module 2 (Quality Overall Summary) and Module 3 (Quality).

Where is the job location?

The role is based in Hyderabad, Telangana.

SEO Title Variations for Higher Visibility

• Aurobindo Pharma EU Regulatory Affairs Jobs Hyderabad
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Summary Table

Category	Details
Company	Aurobindo Pharma Ltd
Vacancies	Regulatory Affairs – EU Markets (Formulation R&D)
Required Education	MPharm
Experience	2 to 10 Years