Aurobindo Hiring Regulatory Affairs Executive

Aurobindo Pharma Regulatory Affairs Executive – MSc Chemistry

Aurobindo Pharma hiring Regulatory Affairs Executive/Senior Executive. MSc Chemistry with 5–7 years experience in API Module 3 & post-approval changes.

Aurobindo Pharma is expanding its Regulatory Affairs function and inviting experienced regulatory professionals to join its API-focused regulatory team. This opportunity is designed for candidates with strong exposure to regulatory documentation, post-approval change management, and CTD Module 3 preparation within a regulated pharmaceutical environment. The role offers direct involvement in global regulatory submissions and long-term career growth within one of India’s most established pharmaceutical organizations.

Company Overview

Aurobindo Pharma is a globally recognized pharmaceutical company with a strong footprint across APIs, formulations, and specialty products. Known for its robust regulatory compliance framework and consistent approvals across regulated markets, the organization operates with a strong focus on quality, data integrity, and lifecycle management of pharmaceutical products. The Regulatory Affairs division plays a critical role in ensuring timely submissions, approvals, and post-approval compliance across global markets.

Job Role & Responsibilities

As part of the Regulatory Affairs Department, the selected Executive or Senior Executive will be responsible for managing API regulatory documentation and supporting post-approval regulatory activities.

Key responsibilities include:

• Preparation, review, and submission of regulatory documents related to APIs
• Drafting and reviewing CTD Module 3 sections in line with global regulatory requirements
• Handling regulatory guidance documents related to post-approval changes
• Supporting variations, amendments, and lifecycle management activities
• Coordinating with internal stakeholders including QA, QC, R&D, and manufacturing teams
• Ensuring compliance with global regulatory guidelines and data integrity standards
• Tracking regulatory updates and implementing changes in documentation strategies

Eligibility / Qualifications

Candidates applying for this role should meet the following criteria:

• Educational Qualification: MSc in Chemistry
• Relevant Courses: Pharmaceutical Chemistry, Analytical Chemistry, Organic Chemistry, Medicinal Chemistry
• Experience: 5 to 7 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry
• Mandatory experience in API regulatory documentation and Module 3 drafting/review

Required Skill Set

• Strong understanding of regulatory guidance documents
• Proven experience in post-approval change documentation
• Expertise in CTD and eCTD Module 3 for APIs
• Knowledge of global regulatory expectations
• Good documentation practices and attention to detail
• Ability to work cross-functionally in a regulated environment

Location & Salary

The job location and compensation details will be aligned with industry standards and commensurate with experience. Aurobindo Pharma offers competitive salary packages along with long-term career stability.

Application Process

Interested and eligible candidates are encouraged to apply through the company’s official recruitment channels. Shortlisted candidates will be contacted for further evaluation.

Frequently Asked Questions (FAQs)

Who can apply for this Regulatory Affairs role?
Candidates with an MSc in Chemistry and 5–7 years of experience in API regulatory affairs can apply.

Is experience in Module 3 mandatory?
Yes. Hands-on experience in drafting or reviewing CTD Module 3 for APIs is essential.

Is this role suitable for formulation regulatory professionals?
This role is primarily focused on API regulatory documentation. API experience is strongly preferred.

What level is this position?
Openings are available at both Executive and Senior Executive levels based on experience.

Company                         Aurobindo Pharma
Vacancies                         Executive / Senior Executive
Required Education         MSc Chemistry
Experience                       5–7 Years