Lupin Hiring Officer – Regulatory Affairs (US Market)

Lupin Hiring Officer – Regulatory Affairs in Airoli, Maharashtra (US Market)

Lupin Limited is hiring for the position of Officer – Regulatory Affairs at its Airoli, Maharashtra location. This opportunity is open to early-career regulatory professionals with 1 to 2 years of experience in regulated market regulatory affairs. The role focuses on USFDA submissions and lifecycle management for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects. This is a single full-time vacancy based in Airoli, Mumbai region, offering hands-on exposure to global regulatory operations within one of India’s most respected pharmaceutical companies.

This role is well suited for pharmacy and science graduates aiming to build long-term careers in regulatory affairs, US market compliance, and global pharmaceutical development.

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Company Overview

Lupin Limited is a globally recognized pharmaceutical company with a strong presence across branded and generic formulations, complex generics, APIs, and specialty products. Headquartered in India, Lupin operates manufacturing and research facilities worldwide and serves regulated and emerging markets including the United States, Europe, and Japan.

The company is known for its deep regulatory expertise, strong compliance culture, and sustained focus on quality, patient safety, and innovation. Lupin’s regulatory teams play a critical role in enabling timely product approvals, managing post-approval commitments, and supporting global commercialization strategies.

Working at Lupin provides exposure to complex dosage forms, global regulatory interactions, and structured career development within a scientifically driven and compliance-focused organization. Employees benefit from cross-functional collaboration, continuous learning, and the opportunity to contribute directly to affordable and accessible healthcare solutions.

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Job Role & Responsibilities

The Officer – Regulatory Affairs will be responsible for supporting and managing regulatory activities for US market products across multiple dosage forms. The role involves close coordination with internal stakeholders, external partners, and regulatory authorities to ensure timely submissions and ongoing compliance.

US Regulatory Submissions & Compliance

• Lead and support regulatory submissions for Inhalation, Nasal, Oral Solid Dosage, Contract Manufacturing, and Strategic Alliance projects for the US market
• Prepare, compile, review, and submit regulatory dossiers in line with USFDA requirements
• Ensure submissions meet current regulatory guidelines, timelines, and quality standards

Regulatory Deficiency Management

• Coordinate timely and compliant responses to regulatory deficiencies, queries, and information requests issued by US regulatory authorities
• Support resolution of USFDA observations by collaborating with cross-functional teams
• Track commitments and ensure closure within agreed timelines

Post-Approval & Lifecycle Management

• Manage post-approval submissions including supplements, variations, and amendments for approved products
• Prepare and submit annual reports for USFDA-approved products
• Ensure continuous compliance throughout the product lifecycle

Labeling & Safety Support

• Drive labeling updates based on changes to Reference Listed Drug (RLD) labeling approved by the USFDA
• Ensure alignment of product labels with regulatory expectations and approved content
• Provide regulatory support for PADER submissions, contributing to pharmacovigilance and patient safety activities

Documentation Review & Strategic Input

• Review regulatory documentation across product development, scale-up, and commercial manufacturing stages
• Provide strategic regulatory input to support development timelines and approval strategies
• Review documentation for externally manufactured products to ensure consistency, compliance, and quality

This role requires strong attention to detail, regulatory knowledge, and the ability to work effectively across functions in a fast-paced, regulated environment.

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Eligibility / Qualifications

This position is intended for candidates with foundational experience in regulatory affairs within regulated pharmaceutical markets.

Educational Qualifications

The following educational backgrounds are eligible:

B.Pharm, M.Pharm, B.Sc, M.Sc Pharmaceutical Sciences, M.Sc Chemistry, M.Sc Life Sciences

Experience Requirements

• 1 to 2 years of hands-on experience in Regulatory Affairs
• Prior exposure to regulated markets, particularly the US market, is required
• Experience with USFDA submissions, post-approval changes, or regulatory documentation is preferred

Key Competencies

• Customer centricity and quality mindset
• Strong collaboration and stakeholder management skills
• Strategic thinking and regulatory agility
• Process excellence and documentation discipline
• Result orientation with attention to compliance
• Willingness to learn and adapt in a regulated environment

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Location & Salary

Job Location: Airoli, Maharashtra, India

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Application Process

Interested and eligible candidates must apply through Lupin’s official career portal using the link below:

Apply Online:
https://careers.lupin.com/job/Airoli-Officer-Regulatory-Affairs-MH/1347959700/?utm_source=LINKEDIN&utm_medium=referrer

Candidates are encouraged to apply at the earliest, as applications are reviewed on an ongoing basis.

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Frequently Asked Questions (FAQs)

Who can apply for the Officer – Regulatory Affairs role at Lupin?
Candidates with a pharmacy or science background and 1–2 years of regulatory affairs experience in regulated markets can apply.

Is this role focused on the US market?
Yes. The position primarily supports USFDA submissions, post-approval changes, and lifecycle management.

Is this a fresher role?
No. Prior regulatory affairs experience is mandatory for this position.

Does this role involve post-approval activities?
Yes. The role includes post-approval submissions, annual reports, labeling updates, and compliance activities.

Is this a permanent position?
Yes. This is a full-time permanent role with long-term career progression opportunities.

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Summary Table

Company	Lupin Limited
Vacancies	Officer – Regulatory Affairs
Required Education	B.Pharm, M.Pharm, B.Sc, M.Sc Pharmaceutical Sciences, M.Sc Chemistry, M.Sc Life Sciences
Experience	1 to 2 Years