Indus Pharma Hirimg Regulatory Affairs Executive / Manager

Regulatory Affairs Executive Job for M.Pharm Graduates | 3-8 Yrs Exp | Rajasthan

Apply for Regulatory Affairs Executive at Indus Pharma, Rajasthan. M.Pharm with 3-8 yrs experience in injectable regulatory affairs preferred.

Explore Career in Regulatory Affairs with Indus Pharma – M.Pharm Jobs in Rajasthan

Are you a skilled professional in pharmaceutical regulatory affairs? Indus Pharma Pvt. Ltd., a leading name in the injectable manufacturing segment, is hiring for Regulatory Affairs Executive / Manager roles at its WHO-GMP-compliant injectable plant in RIICO Industrial Area, Ghiloth, Rajasthan. If you hold an M.Pharm degree and have 3 to 8 years of experience in regulatory affairs for injectables, this could be your next career move.

About Indus Pharma Pvt. Ltd.

Indus Pharma is recognized for its high-quality injectable formulations and compliance with international regulatory standards. With advanced infrastructure and global market focus, the company is now expanding its regulatory affairs team to manage dossier submissions and global compliance operations.

Vacancy Overview – Regulatory Affairs Executive/Manager

Location: RIICO Industrial Area, Ghiloth, Rajasthan
Department: Regulatory Affairs (Injectables)
Experience: 3 to 8 years
Educational Qualification: M.Pharm (Regulatory Affairs, Pharmaceutics or related specialization)

Key Responsibilities

Regulatory Documentation & Dossier Preparation

• Prepare and review CTD/eCTD/ACTD submissions for global markets (ROW, semi-regulated, regulated).
• Handle product variation filings, renewals, and regulatory updates.

Compliance and Documentation

• Ensure regulatory submissions adhere to WHO, ICH, and market-specific requirements.
• Review and approve product labeling and packaging artworks.
• Maintain and audit regulatory documents and submissions.

Communication & Liaison

• Coordinate with CDSCO, state FDA, and international regulatory authorities.
• Address deficiency letters and regulatory queries promptly.
• Liaise with third-party regulatory consultants when required.

Market Expansion Support

• Assist in product registrations for LATAM, Africa, ASEAN, CIS, and the Middle East.
• Monitor changing regulations and advise internal teams accordingly.

Skills Required

• Expertise in regulatory guidelines (ICH, WHO, country-specific)
• Knowledge of CTD/eCTD formats
• Strong communication and documentation abilities
• Proficiency with MS Office, regulatory software, and documentation tools

How to Apply
Interested and eligible candidates can send their resume to hr@induspharmaindia.com with the subject line: Application for Regulatory Affairs – Injectable Plant (Ghiloth).

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