Aurigene Hiring Regulatory Affairs

Regulatory Affairs Jobs – Aurigene Oncology | 4–8 Yrs

Aurigene Oncology hiring Regulatory Affairs professionals with CDSCO/DCGI experience. Apply now for pharma regulatory jobs in India.

Aurigene Oncology is inviting applications from experienced Regulatory Affairs professionals to support its growing oncology portfolio in the Indian pharmaceutical market. This opportunity is designed for candidates with hands-on exposure to CDSCO and DCGI regulatory submissions who want to work in a research-driven oncology organization.

This role is ideal for professionals searching for regulatory affairs jobs in pharma, CDSCO regulatory roles, DCGI submission careers, oncology regulatory affairs positions, and senior regulatory jobs in India. Aurigene offers a strong scientific environment where regulatory expertise directly contributes to advancing cancer therapies.

Company Overview

Aurigene Oncology is a research-focused biopharmaceutical company dedicated to the discovery and development of novel oncology therapies. Backed by deep scientific expertise and a strong R&D foundation, Aurigene focuses on small molecules and biologics aimed at addressing unmet medical needs in cancer treatment.

The organization operates with global quality standards and aligns regulatory strategy closely with clinical development and commercialization goals. Working at Aurigene provides exposure to complex regulatory pathways, innovation-driven development programs, and meaningful contributions to patient care in oncology.

Job Role & Responsibilities

Regulatory Affairs – Oncology

The Regulatory Affairs professional will manage and support regulatory activities for India market submissions.

Key responsibilities include:

• Preparing, reviewing, and submitting regulatory dossiers to CDSCO and DCGI
• Managing variations, renewals, and post-approval changes
• Coordinating with cross-functional teams including R&D, QA, QC, and clinical teams
• Ensuring compliance with Indian regulatory guidelines and timelines
• Responding to regulatory queries and deficiency letters
• Supporting regulatory strategy for oncology products
• Maintaining regulatory documentation and submission tracking

Eligibility / Qualifications

Educational Qualification

M.Pharm, B.Pharm, M.Sc (Life Sciences), or any relevant pharmaceutical or scientific degree

Experience Requirement

• 4 to 8 years of experience in Regulatory Affairs
• Strong hands-on exposure to India market submissions
• Practical knowledge of CDSCO and DCGI regulatory requirements
• Experience in oncology or complex dosage forms is preferred

Location & Salary

The job location will be as per Aurigene Oncology’s operational requirements in India. Salary and benefits will be competitive and aligned with industry standards, based on experience and expertise. Final compensation details will be discussed during the interview process.

Application Process

Interested and eligible candidates may share their updated resume at:

• sushmitha@aurigene.com

Candidates are advised to mention “Regulatory Affairs – India Market” in the subject line for faster screening.

FAQs

Who can apply for this role?

Professionals with 4–8 years of Regulatory Affairs experience and CDSCO/DCGI exposure can apply.

Is India market experience mandatory?

Yes. Strong exposure to CDSCO and DCGI submissions is required.

Is oncology experience mandatory?

Oncology experience is preferred but not mandatory if the candidate has strong regulatory exposure.

What type of regulatory work is involved?

The role involves submissions, variations, post-approval changes, and regulatory strategy support.

How do I apply?

Email your updated resume to sushmitha@aurigene.com.

Summary Table

Company	Aurigene Oncology
Vacancies	Regulatory Affairs
Required Education	B.Pharm, M.Pharm, M.Sc
Experience	4–8 Years