Lupin Hiring Officer Regulatory Affairs Jobs in Airoli for USFDA submissions, post-approval activities, and lifecycle management roles.
About the Company
Lupin Limited is one of India’s leading global pharmaceutical companies with a strong footprint in regulated and emerging markets. The company operates across branded and generic formulations, complex generics, APIs, and specialty products, serving key markets such as the United States, Europe, and Japan. Lupin Hiring Officer Regulatory Affairs Jobs
Lupin is widely recognized for its robust regulatory framework, strong compliance culture, and commitment to quality, patient safety, and innovation. Its regulatory affairs teams play a crucial role in enabling timely product approvals, managing lifecycle compliance, and supporting global commercialization strategies.
Working at Lupin offers exposure to complex dosage forms, global regulatory interactions, and structured career growth within a compliance-driven, science-focused environment. Lupin Hiring Officer Regulatory Affairs Jobs
Job Details
- Job Title: Officer – Regulatory Affairs
- Employment Type: Full Time
- Location: Airoli, Maharashtra, India
- Market Focus: US (USFDA Regulated Market)
- Experience Level: Early Career (1–2 Years)
- Posted: Recently
Job Description
Lupin Limited is hiring an Officer – Regulatory Affairs for its Airoli facility to support US market regulatory activities. This role is designed for regulatory professionals with hands-on experience in regulated markets, particularly the United States. Lupin Hiring Officer Regulatory Affairs Jobs
The position focuses on USFDA submissions, post-approval lifecycle management, labeling compliance, and regulatory coordination for multiple dosage forms, including Inhalation, Nasal, Oral Solid Dosage, Contract Manufacturing, and Strategic Alliance products.
This is an excellent opportunity for pharmacy and science graduates seeking long-term careers in US regulatory affairs and global pharmaceutical development. Lupin Hiring Officer Regulatory Affairs Jobs
Key Responsibilities
US Regulatory Submissions and Compliance
- Prepare, compile, review, and submit regulatory dossiers for USFDA
- Support submissions for Inhalation, Nasal, OSD, Contract Manufacturing, and Strategic Alliance projects
- Ensure submissions comply with current USFDA guidelines, timelines, and quality standards
Regulatory Deficiency Management
- Coordinate responses to USFDA deficiencies, queries, and information requests
- Collaborate with cross-functional teams to address regulatory observations
- Track commitments and ensure timely closure
Post-Approval and Lifecycle Management
- Manage post-approval submissions, supplements, amendments, and variations
- Prepare and submit annual reports for USFDA-approved products
- Ensure continuous regulatory compliance throughout the product lifecycle
Labeling and Safety Support
- Implement labeling updates based on Reference Listed Drug changes approved by USFDA
- Ensure label content aligns with approved regulatory requirements
- Provide regulatory support for PADER submissions and pharmacovigilance activities
Documentation Review and Strategic Input
- Review regulatory documentation across development, scale-up, and commercial stages
- Provide strategic regulatory inputs to support approval timelines
- Review documents for externally manufactured products to ensure compliance and consistency
Lupin Hiring Officer Regulatory Affairs Jobs
Skills and Qualifications
Educational Qualifications
Candidates must possess one of the following degrees:
- B.Pharm
- M.Pharm
- B.Sc
- M.Sc Pharmaceutical Sciences
- M.Sc Chemistry
- M.Sc Life Sciences
Experience Requirements
- 1 to 2 years of experience in Regulatory Affairs
- Mandatory exposure to regulated markets
- Prior experience with USFDA submissions and post-approval activities preferred
Key Competencies
- Strong regulatory and compliance mindset
- Excellent documentation and attention to detail
- Ability to collaborate across cross-functional teams
- Strategic thinking with regulatory agility
- Process-oriented and quality-focused approach
- Willingness to learn and adapt in a regulated environment
Benefits and Perks
- Exposure to USFDA-regulated global projects
- Hands-on experience with complex dosage forms
- Structured career growth in regulatory affairs
- Collaborative and compliance-driven work culture
- Opportunity to work with a globally respected pharmaceutical organization
Why You Should Join
Joining Lupin’s Regulatory Affairs team provides a unique opportunity to build expertise in US market compliance while working on diverse and complex pharmaceutical products. The role offers strong learning exposure, global regulatory interaction, and a stable long-term career path within one of India’s most trusted pharmaceutical companies. Lupin Hiring Officer Regulatory Affairs Jobs
Frequently Asked Questions (FAQs)
Who is eligible for this role?
Candidates with pharmacy or science backgrounds and 1–2 years of regulatory affairs experience in regulated markets.
Is this a US market–focused role?
Yes, the position primarily supports USFDA submissions and lifecycle management activities.
Is this a fresher job?
No, prior regulatory affairs experience is mandatory.
Does the role include post-approval work?
Yes, post-approval submissions, annual reports, labeling updates, and compliance activities are key responsibilities.
Is this a permanent position?
Yes, this is a full-time permanent role with long-term career growth opportunities.
How to Apply
Interested and eligible candidates should apply through Lupin Limited’s official career portal using the link below:
Early application is recommended, as profiles are reviewed on a rolling basis. Lupin Hiring Officer Regulatory Affairs Jobs
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
