Regulatory Affairs Officer Job at Lupin Limited in Airoli Mumbai. USFDA submissions, labeling updates and lifecycle management pharma career opportunity.
Company Overview
Lupin Limited is one of India’s leading pharmaceutical companies with a strong global presence in over 100 countries. Headquartered in Mumbai, Lupin specializes in the development, manufacturing, and marketing of pharmaceutical products across multiple therapeutic segments including cardiovascular, respiratory, anti-infectives, diabetes, and central nervous system disorders.
The company has built a strong reputation in regulated markets such as the United States, Europe, and Japan. With advanced manufacturing facilities and a strong research and development infrastructure, Lupin continues to focus on innovation, regulatory excellence, and high-quality pharmaceutical products.
Professionals joining Lupin gain exposure to global regulatory environments, advanced drug development programs, and collaborative international healthcare projects. Regulatory Affairs Officer Job at Lupin Limited
Job Location & Employment Type
- Company: Lupin Limited
- Position: Officer – Regulatory Affairs
- Job Location: Airoli, Navi Mumbai, Maharashtra, India
- Employment Type: Full-Time
- Industry: Pharmaceutical / Regulatory Affairs
This role focuses on regulatory submissions and lifecycle management for pharmaceutical products in the United States market. Regulatory Affairs Officer Job at Lupin Limited
Open Position / Department Details
Officer – Regulatory Affairs
Lupin is seeking a Regulatory Affairs Officer to support regulatory submission activities and compliance requirements for products intended for the US market.
The selected candidate will be responsible for preparing and managing regulatory submissions, responding to regulatory queries, and ensuring that pharmaceutical products comply with regulatory guidelines throughout their lifecycle.
This role offers a valuable opportunity for professionals interested in building a career in regulated market regulatory affairs, particularly related to the USFDA. Regulatory Affairs Officer Job at Lupin Limited
Key Roles & Responsibilities
The Regulatory Affairs Officer will support regulatory operations and ensure compliance with international regulatory requirements.
Regulatory Submission Management
- Lead regulatory submission activities for pharmaceutical products intended for the United States market.
- Manage regulatory documentation related to Inhalation products, Nasal formulations, Oral Solid Dosage (OSD) products, Contract Manufacturing, and Strategic Alliance projects.
- Prepare submission dossiers and ensure all documentation complies with regulatory standards.
Regulatory Agency Communication
- Coordinate responses to product deficiencies or queries raised by regulatory authorities, including the US Food and Drug Administration (USFDA).
- Ensure timely submission of responses to regulatory agencies.
Lifecycle Management and Post-Approval Activities
- Manage post-approval regulatory submissions for approved pharmaceutical products.
- Prepare and submit annual reports required for USFDA-approved products.
- Ensure continuous compliance with regulatory requirements during product lifecycle management.
Labeling Compliance
- Monitor labeling changes related to Reference Listed Drugs (RLD).
- Implement necessary labeling updates according to USFDA-approved changes.
- Ensure product labels remain compliant with regulatory standards.
Pharmacovigilance and Safety Reporting
- Provide regulatory support for Periodic Adverse Drug Experience Reports (PADER).
- Collaborate with pharmacovigilance teams to ensure proper safety reporting and regulatory compliance.
Documentation Review and Regulatory Strategy
- Review regulatory documentation related to product development, scale-up, and commercial manufacturing.
- Provide strategic regulatory input during product development processes.
- Ensure documentation meets regulatory and quality standards.
External Manufacturing Compliance
- Review regulatory documents for externally manufactured pharmaceutical products.
- Ensure regulatory alignment and consistency for contract manufacturing partners.
Regulatory Affairs Officer Job at Lupin Limited
Eligibility Criteria
Education
Candidates must possess one of the following qualifications:
- Bachelor’s Degree in Pharmacy (B.Pharm)
- Master’s Degree in Science (M.Sc.)
Applicants with educational backgrounds related to pharmaceutical sciences or regulatory affairs will be preferred. Regulatory Affairs Officer Job at Lupin Limited
Experience
- 1 to 2 years of experience in Regulatory Affairs for regulated markets.
- Experience working with regulatory documentation related to international pharmaceutical markets is preferred.
- Exposure to USFDA regulatory requirements will be considered an advantage.
Skills Required
Applicants should demonstrate both technical regulatory knowledge and strong professional skills.
Regulatory Knowledge
- Understanding of regulatory submission processes for regulated markets
- Familiarity with USFDA regulatory requirements and submission procedures
- Knowledge of product lifecycle management and post-approval submissions
Technical Skills
- Experience reviewing regulatory documentation and submission dossiers
- Understanding of labeling requirements and regulatory updates
- Knowledge of pharmacovigilance reporting systems
Professional Competencies
Candidates should demonstrate the following competencies:
- Customer-centric mindset
- Strong collaboration and teamwork abilities
- Strategic thinking and regulatory problem-solving skills
- Stakeholder management capabilities
- Process improvement and operational efficiency mindset
- Innovation and creative problem-solving
- Strong focus on achieving results and meeting deadlines
Salary & Benefits
Compensation for this role will be offered as per company norms and industry standards, depending on the candidate’s experience and qualifications. Regulatory Affairs Officer Job at Lupin Limited
Employees may also benefit from:
- Competitive salary packages
- Exposure to global regulatory affairs processes
- Career growth opportunities within the pharmaceutical regulatory domain
- Training and professional development programs
- Opportunities to work with international regulatory teams
Selection Process
The recruitment process typically includes the following steps:
- Resume screening and application review
- HR or recruiter discussion
- Technical interview with regulatory affairs team
- Final interview with hiring managers
- Offer and onboarding process
The exact process may vary depending on company requirements. Regulatory Affairs Officer Job at Lupin Limited
How to Apply
Interested candidates can apply online through the official careers portal of Lupin Limited for the Officer – Regulatory Affairs position located in Airoli, Navi Mumbai.
Applicants are advised to highlight their experience in regulatory submissions, USFDA documentation, and pharmaceutical regulatory compliance when applying. Regulatory Affairs Officer Job at Lupin Limited
Important Dates
- Application Deadline: Not specified
Early applications are recommended as positions may close once suitable candidates are shortlisted.
Why Apply for This Pharma Job?
This opportunity offers an excellent career pathway for professionals interested in regulatory affairs within the pharmaceutical industry. Regulatory Affairs Officer Job at Lupin Limited
Key advantages include:
- Exposure to USFDA regulatory submission processes
- Experience working on multiple pharmaceutical dosage forms
- Opportunity to participate in product lifecycle regulatory management
- Collaboration with global regulatory and pharmacovigilance teams
- Career development in regulated market regulatory affairs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes employment opportunities in the pharmaceutical, biotechnology, and healthcare sectors.
We are not affiliated with Lupin Limited or any company mentioned in this job post. Candidates should verify all job details and apply through the official company careers portal. Regulatory Affairs Officer Job at Lupin Limited
Final Call-to-Action
Candidates with experience in pharmaceutical regulatory affairs and regulated market submissions are encouraged to apply and advance their careers in global regulatory operations. Regulatory Affairs Officer Job at Lupin Limited
