Dive into regulatory affairs pharma jobs! Lupin seeks Officers for US market submissions in Airoli. Ideal for 1-2 years exp in regulated markets. Advance your pharmaceutical careers in India today.
About the Company
Lupin Limited is a multinational pharmaceutical powerhouse headquartered in Mumbai, India, with a global footprint across 100+ countries and revenues exceeding $1.5 billion.
Renowned for its robust generics portfolio, innovative branded drugs, and focus on therapeutics like cardiovascular, diabetes, and respiratory, Lupin invests heavily in R&D with state-of-the-art facilities.
Committed to regulatory excellence, ethical compliance, and sustainable growth, the company holds approvals from stringent bodies like USFDA and EMA, empowering professionals to deliver life-enhancing therapies while fostering a culture of innovation and collaboration.
Job Details
- Company Name: Lupin Limited
- Experience: 1-2 years
- Qualification: Graduation in Pharmacy; Master’s in Science
- Location: Airoli, Maharashtra, India
- Work Type: On-site
Job Description
Lupin is strengthening its Regulatory Affairs team to navigate complex US market requirements for inhalation, nasal, and OSD products. This role plays a pivotal part in ensuring seamless submissions and compliance, supporting strategic alliances and contract manufacturing. Thrive in a high-stakes environment where precision drives global product launches.
Officer – Regulatory Affairs
- Department: Regulatory Affairs
- Market: US regulated pharmaceutical market
- Role: Lead submissions, manage deficiencies, and support lifecycle compliance for USFDA products
- Experience: 1-2 years in Regulatory Affairs for regulated markets
- Education/Qualification: Graduation in Pharmacy; Master’s in Science
Skills/Qualifications
- Expertise in USFDA submission processes for inhalation and OSD forms
- Proficiency in handling post-approval changes and annual reporting
- Strong knowledge of pharmacovigilance, including PADER requirements
- Analytical skills for reviewing development and manufacturing documentation
- Competencies in customer centricity, strategic agility, and stakeholder management
- Ability to drive innovation and process excellence in regulatory strategies
- Excellent collaboration and result-oriented mindset
- Familiarity with labeling updates aligned to RLD changes
Key Responsibilities
- Lead regulatory submissions for US inhalation projects
- Respond timely to USFDA deficiency notices
- Manage post-approval submissions and annual reports
- Drive RLD-aligned labeling updates
- Support PADER for global safety monitoring
- Review documentation for product scale-up stages
- Oversee external manufacturing regulatory reviews
Benefits/Perks
- Competitive salary with performance-based incentives
- Comprehensive career growth in global pharma leadership
- Ongoing training in regulatory compliance and USFDA guidelines
- Collaborative work culture emphasizing innovation
- Health insurance and wellness programs
- Opportunities for international exposure and alliances
How to Apply
To apply for the Officer – Regulatory Affairs position, visit Lupin’s official careers portal at www.lupin.com/careers and search for the latest openings in Airoli, or email your resume to careers@lupin.com with “Officer – Regulatory Affairs – Airoli” in the subject line.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Lupin Career page.
Include your experience in regulated markets. For more pharma jobs and application tips, explore Pharma Recruiter. Take the next step—apply now and shape the future of compliant pharma innovation!
Why You Should Join
Lupin cultivates a dynamic culture of recognition and empowerment, where regulatory experts are celebrated for their strategic contributions to blockbuster launches and market expansions. Gain unparalleled career stability in a resilient global pharma leader navigating regulatory complexities with agility and foresight.
Harness limitless learning through specialized USFDA training, cross-functional projects, and mentorship programs, all within a compliant, innovative ecosystem that prioritizes patient-centric solutions and ethical excellence. At Lupin, your regulatory acumen fuels transformative therapies and a legacy of professional triumph.
FAQs
What experience is required for Lupin’s Regulatory Affairs Officer role?
1-2 years in Regulatory Affairs for regulated markets, focusing on USFDA submissions.
What qualifications do I need for this pharma job?
Graduation in Pharmacy and Master’s in Science; expertise in inhalation/OSD regulations preferred.
How do I apply for regulatory affairs jobs at Lupin?
Visit www.lupin.com/careers or email careers@lupin.com. For broader opportunities, check Pharma Recruiter.
What growth prospects exist in this position?
Rapid advancement to senior regulatory roles, with training in global pharmacovigilance and strategic alliances.