Lupin Hiring Regulatory Affairs professionals

BPharm candidates required for Executive RA US ANDA vacancies at Lupin, Airoli. 2–3 years experience required.

Regulatory Affairs professionals with exposure to USFDA filings are in high demand as pharmaceutical companies expand their presence in regulated markets. Lupin is hiring an Executive – Regulatory Affairs (US ANDA) at its Airoli facility in Maharashtra. This role is ideal for pharmacy graduates with hands-on experience in US regulatory submissions who want to work on high-impact generic drug approvals for the US market.

Company Overview

Lupin is a globally recognized pharmaceutical company with a strong footprint across the United States, India, Europe, and emerging markets. The company is known for its leadership in generic formulations, complex products, and active pharmaceutical ingredients, with a growing focus on regulated markets such as the US, Europe, and Japan.

With decades of experience in regulatory science and pharmaceutical manufacturing, Lupin has built a reputation for quality, compliance, and innovation. The company’s portfolio spans oral solid dosage forms, injectables, biosimilars, and specialty products across multiple therapeutic segments.

Lupin’s regulatory affairs teams play a critical role in ensuring timely product approvals, lifecycle management, and ongoing compliance with global regulatory agencies, including the US Food and Drug Administration.

Job Role & Responsibilities

The Executive – RA (US ANDA) role is a core regulatory position focused on USFDA submissions and post-approval compliance for Oral Solid Dosage products.

Key responsibilities include:

• Leading regulatory submissions for US ANDA dossiers related to Oral Solid Dosage forms
• Preparing, reviewing, and coordinating responses to deficiency letters issued by USFDA
• Managing post-approval submissions, supplements, and annual reports for approved ANDAs
• Ensuring continuous regulatory compliance throughout the product lifecycle
• Driving labeling updates in line with Reference Listed Drug labeling approved by USFDA
• Providing regulatory support for PADER submissions as part of pharmacovigilance activities
• Reviewing regulatory documentation across product development, scale-up, and commercial manufacturing stages
• Supporting regulatory review of externally manufactured products to ensure consistency and compliance
• Collaborating with cross-functional teams including formulation, quality assurance, manufacturing, and pharmacovigilance

This role offers direct exposure to USFDA regulatory strategy, lifecycle management, and compliance-driven pharmaceutical development.

Eligibility / Qualifications

This position is suitable for experienced regulatory professionals with hands-on exposure to US ANDA filings.

Required qualifications:

• Graduation in Pharmacy (BPharm or equivalent)
• 2 to 3 years of experience in Regulatory Affairs with focus on US ANDA submissions
• Strong understanding of USFDA regulatory requirements for Oral Solid Dosage products
• Experience handling deficiency responses, post-approval changes, and annual reports
• Familiarity with regulatory documentation, lifecycle management, and labeling updates
• Strong coordination and stakeholder management skills
• Attention to detail and result-oriented approach to regulatory timelines

Relevant education background includes:
BPharm, MPharm, Pharmaceutics, Pharmaceutical Regulatory Affairs, Industrial Pharmacy

Location & Salary

Job Location: Airoli, Maharashtra

The role is based at Lupin’s Airoli facility. Salary details are not publicly disclosed; however, Lupin offers competitive compensation packages aligned with regulatory affairs roles in the Indian pharmaceutical industry.

Employees can expect:

• Competitive salary and performance-linked growth
• Exposure to USFDA-regulated product portfolios
• Long-term career growth in regulatory affairs and compliance leadership
• Stable work environment with strong compliance culture

Application Process

Interested candidates can apply online through Lupin’s official careers portal using the link below:

Apply Online: https://careers.lupin.com/job/Airoli-Executive-RA-%28US-ANDA%29-MH/1357547400/?utm_source=LINKEDIN&utm_medium=referrer

Shortlisted candidates will be contacted by the Lupin recruitment team for further steps in the hiring process.

Frequently Asked Questions

Is this role suitable for freshers?

No. This position requires 2–3 years of hands-on experience in US ANDA regulatory submissions.

What dosage forms does this role focus on?

The role primarily focuses on Oral Solid Dosage products for the US market.

Does the role involve USFDA interaction?

Yes. The role involves responding to USFDA deficiencies and managing post-approval submissions.

Are there growth opportunities in this role?

Yes. Professionals can progress into senior regulatory affairs, regulatory strategy, and global RA roles.

Is this a full-time position?

Yes. This is a full-time regulatory affairs position.

High-Value SEO & AdSense Keywords Used Naturally

US regulatory affairs jobs, US ANDA submissions, regulatory affairs executive pharma, USFDA compliance jobs, pharmaceutical regulatory careers, high-paying RA jobs

Category	Details
Company	Lupin
Vacancies	Executive – RA (US ANDA)
Required Education	BPharm, MPharm, Pharmaceutics
Experience	2–3 Years