Regulatory Affairs Executive Job at Lupin US ANDA role at Lupin Mumbai. Pharma graduates with 2–3 years experience can apply.
Introduction
A promising career opportunity is now open for pharmaceutical professionals looking to build expertise in global regulatory affairs. Lupin, a well-established name in the pharmaceutical industry, is inviting applications for the position of Executive – Regulatory Affairs (US ANDA). This role is ideal for candidates who have hands-on experience in US regulatory submissions and are eager to work on Oral Solid Dosage (OSD) products for international markets. If you are aiming to strengthen your career in regulatory strategy and compliance, this opportunity can be a strong step forward. Regulatory Affairs Executive Job at Lupin
Company Overview
Lupin is one of India’s leading pharmaceutical companies with a strong presence in global markets, particularly in the United States. The company focuses on delivering high-quality, affordable medicines across various therapeutic segments. With advanced research capabilities, manufacturing excellence, and regulatory expertise, Lupin continues to play a significant role in the global healthcare sector. Working at Lupin offers professionals exposure to international regulatory frameworks, innovation-driven projects, and a collaborative work environment. Regulatory Affairs Executive Job at Lupin
Job Overview (Job Details)
| Job Title | Executive – Regulatory Affairs (US ANDA) |
|---|---|
| Company | Lupin |
| Location | Airoli, Mumbai, Maharashtra |
| Department | Regulatory Affairs |
| Employment Type | Full-Time |
| Experience Required | 2 to 3 Years |
| Qualification | Bachelor’s Degree in Pharmacy |
| Industry | Pharmaceutical |
| Functional Area | Regulatory Affairs – US Market |
| Application Mode | Online |
Job Location & Employment Type
- Work Location: Airoli, Navi Mumbai, Maharashtra
- Employment Type: Full-time, permanent role
- Work Environment: Corporate regulatory office with cross-functional collaboration
Open Position / Department Details
- Department: Regulatory Affairs – US ANDA
- Designation: Executive
- Focus Area: Oral Solid Dosage (OSD) submissions for the US market
- Reporting: Regulatory Affairs Team Lead / Manager
This position involves active participation in regulatory submission processes, lifecycle management, and compliance activities related to USFDA guidelines. Regulatory Affairs Executive Job at Lupin
Key Roles & Responsibilities
The selected candidate will be responsible for handling various regulatory activities related to ANDA filings and post-approval processes. Key responsibilities include: Regulatory Affairs Executive Job at Lupin
- Managing and preparing regulatory submissions for Oral Solid Dosage forms targeted for the US market
- Coordinating responses to queries, deficiencies, or observations raised by regulatory authorities, including USFDA
- Supporting lifecycle management activities such as supplements, variations, and annual reports
- Monitoring updates in Reference Listed Drug (RLD) labeling and ensuring timely implementation in company products
- Assisting in preparation and review of PADER (Periodic Adverse Drug Experience Reports) to support pharmacovigilance requirements
- Collaborating with cross-functional teams including formulation development, manufacturing, and quality assurance
- Reviewing technical documents related to product development, scale-up, and commercialization
- Ensuring compliance with global regulatory standards and internal quality guidelines
- Handling documentation review for third-party manufactured products to maintain regulatory consistency
Eligibility Criteria
Education
- Bachelor’s Degree in Pharmacy (B.Pharm) from a recognized university
- Candidates with additional regulatory certifications will have an advantage
Experience
- Minimum 2 to 3 years of experience in Regulatory Affairs
- Hands-on experience in US ANDA submissions is mandatory
- Prior exposure to OSD (Oral Solid Dosage) products is required
Skills Required
- Strong understanding of USFDA regulatory requirements and guidelines
- Knowledge of ANDA filing procedures and lifecycle management
- Ability to interpret regulatory updates and implement changes effectively
- Good documentation and technical writing skills
- Strong analytical and problem-solving abilities
- Effective communication and coordination skills
- Attention to detail and compliance-driven mindset
- Ability to work in a team-oriented and deadline-driven environment
Salary & Benefits
- Compensation will be as per company norms
- Additional benefits may include performance incentives, health benefits, and career development opportunities
Regulatory Affairs Executive Job at Lupin
Selection Process
The recruitment process may include the following stages:
- Initial screening of applications
- Technical interview focusing on regulatory knowledge and experience
- HR discussion for final selection
Only shortlisted candidates will be contacted for further rounds.
How to Apply
Interested and eligible candidates should apply through the official company career portal. Ensure that your resume highlights relevant experience in US regulatory submissions and OSD product handling. Regulatory Affairs Executive Job at Lupin
Important Dates
- Job Posted On: March 19, 2026
- Candidates are advised to apply at the earliest as positions may close once filled
Why Apply for This Pharma Job?
This opportunity at Lupin offers a strong platform for professionals aiming to build a long-term career in Regulatory Affairs. Working in the US ANDA domain provides valuable exposure to international regulatory standards, which significantly enhances career growth prospects. You will gain experience in handling real-time regulatory challenges, collaborate with experienced professionals, and contribute to the development of globally marketed pharmaceutical products. Additionally, Lupin’s structured work environment and learning culture make it an ideal workplace for skill enhancement and career advancement.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We do not provide any recruitment services and are not affiliated with Lupin or any other company. Candidates are advised to verify job details from the official company website before applying. We do not charge any fees for job information. Regulatory Affairs Executive Job at Lupin
Final Call-to-Action
If you meet the eligibility criteria and are looking to advance your career in US regulatory affairs, apply now and secure your opportunity with Lupin. Regulatory Affairs Executive Job at Lupin
