Lupin Hiring Officer – Regulatory Affairs
- Lupin Hiring Officer – Regulatory Affairs | B.Pharm / M.Sc | 1–2 Years Experience | Airoli
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility & Qualifications
- Educational Qualification
- Experience Requirement
- Core Competencies
- Location & Salary
- Application Process
- Application Tips
- Frequently Asked Questions (FAQs)
- 1. Is this role suitable for freshers?
- 2. Is USFDA experience mandatory?
- 3. What dosage forms are involved in this role?
- 4. What type of submissions will be handled?
- 5. What career growth can be expected?
- 6. Is this a corporate or plant-based role?
Lupin Hiring Officer – Regulatory Affairs | B.Pharm / M.Sc | 1–2 Years Experience | Airoli
Lupin is hiring for the position of Officer – Regulatory Affairs at its Airoli, Maharashtra location. This opportunity is open to Pharmacy and Science graduates with 1–2 years of experience in Regulatory Affairs for regulated markets, particularly the US market. The role sits within the Regulatory Affairs department and focuses on USFDA submissions, lifecycle management, and compliance support for inhalation, nasal, and oral solid dosage (OSD) products.
If you are looking for regulatory affairs jobs in Mumbai, USFDA submission roles in pharma, or career growth in regulated market compliance, this position offers hands-on exposure to global filings and post-approval regulatory strategy within one of India’s leading pharmaceutical companies.
Company Overview
Lupin is a globally recognized pharmaceutical company with a strong presence in branded and generic formulations, biotechnology products, and active pharmaceutical ingredients. The company operates across multiple therapeutic segments including respiratory, cardiovascular, diabetes, central nervous system, and anti-infectives.
With significant operations in the United States and other regulated markets, Lupin has built a reputation for quality manufacturing, regulatory compliance, and research-driven product development. Its facilities are approved by major global regulatory agencies, including the USFDA, and the organization continues to expand through innovation, strategic alliances, and contract manufacturing partnerships.
The Regulatory Affairs team at Lupin plays a critical role in ensuring that products meet international compliance standards across development, approval, and commercialization stages. Professionals in this function directly support global market access, product lifecycle management, and pharmacovigilance reporting.
Job Role & Responsibilities
The Officer – Regulatory Affairs will be responsible for managing regulatory submissions and compliance activities for products intended for the US market. The role demands precision, strong documentation skills, and a deep understanding of USFDA regulations.
Key Responsibilities
- Lead regulatory submissions for Inhalation, Nasal, and Oral Solid Dosage (OSD) products targeting the US market.
- Support filings related to contract manufacturing and strategic alliance projects.
- Prepare and manage responses to product deficiencies raised by US regulatory authorities, including the USFDA.
- Handle post-approval submissions and annual reports for USFDA-approved products.
- Drive labeling updates aligned with changes in Reference Listed Drug (RLD) labeling.
- Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports) submissions.
- Review technical and regulatory documentation across development, scale-up, and commercial manufacturing stages.
- Oversee documentation review for externally manufactured products to ensure compliance and quality consistency.
This position requires strong coordination with cross-functional teams including formulation development, quality assurance, pharmacovigilance, manufacturing, and external partners. Attention to detail and the ability to interpret evolving regulatory guidelines are essential.
By contributing to USFDA filings and lifecycle management activities, the Regulatory Affairs Officer ensures uninterrupted product availability in regulated markets while maintaining strict compliance standards.
Eligibility & Qualifications
Lupin is seeking candidates with a solid academic background and practical exposure to regulated market submissions.
Educational Qualification
Graduation in Pharmacy or Master’s in Science is required.
Accepted qualifications include:
B.Pharm, M.Pharm, MSc Pharmaceutical Sciences, MSc Chemistry, MSc Biotechnology, MSc Life Sciences, Pharm.D or related pharmaceutical and scientific disciplines.
Experience Requirement
- 1 to 2 years of experience in Regulatory Affairs.
- Hands-on exposure to regulated market submissions, preferably USFDA filings.
- Understanding of post-approval changes, labeling updates, and regulatory lifecycle management.
Core Competencies
- Customer centricity and stakeholder management.
- Collaboration with cross-functional teams.
- Strong documentation and review skills.
- Strategic agility and process excellence.
- Innovation and result orientation.
- Ability to manage multiple submissions and timelines efficiently.
Candidates must demonstrate familiarity with regulatory guidelines for ANDA submissions, post-approval variations, and safety reporting requirements. Knowledge of USFDA regulatory pathways and compliance frameworks will be highly valued.
Location & Salary
Location: Airoli, Maharashtra, India
Department: Regulatory Affairs
Experience Level: 1–2 Years
Job Type: Full-Time
Application Process
Interested candidates can apply online through Lupin’s official career portal using the link below:
Application Tips
- Highlight USFDA submission experience clearly in your resume.
- Mention specific exposure to ANDA filings, post-approval changes, or labeling updates.
- Include measurable contributions such as number of submissions handled or response timelines managed.
- Emphasize collaboration with quality, manufacturing, and pharmacovigilance teams.
Shortlisted candidates will be contacted for further evaluation.
Frequently Asked Questions (FAQs)
1. Is this role suitable for freshers?
No. Candidates must have 1–2 years of experience in Regulatory Affairs for regulated markets.
2. Is USFDA experience mandatory?
Experience in regulated markets, especially USFDA submissions, is strongly preferred.
3. What dosage forms are involved in this role?
Inhalation, Nasal, and Oral Solid Dosage (OSD) products.
4. What type of submissions will be handled?
Regulatory filings, post-approval submissions, annual reports, labeling updates, and PADER support.
5. What career growth can be expected?
With experience, professionals can progress to Senior Executive – Regulatory Affairs, Regulatory Manager, or Global Regulatory Strategy roles.
6. Is this a corporate or plant-based role?
The position is based in Airoli and involves regulatory documentation and coordination functions.
| Company | Lupin |
|---|---|
| Vacancies | Officer – Regulatory Affairs |
| Required Education | B.Pharm, M.Pharm, MSc Pharmaceutical Sciences, MSc Chemistry, MSc Biotechnology, MSc Life Sciences, Pharm.D or related disciplines |
| Experience | 1–2 years in Regulatory Affairs for regulated markets (USFDA exposure preferred) |
To apply for this job please visit careers.lupin.com.
