Lupin Hiring Freshers as Regulatory Affairs Officer in Mumbai Apply now for entry-level RA jobs with top pharmaceutical company.
Lupin Limited, one of India’s leading pharmaceutical companies, has announced a new opportunity for freshers and early-career professionals seeking to build a career in Regulatory Affairs (RA). The opening for the position of Officer – Regulatory Affairs at the Santacruz, Mumbai location is an excellent starting point for candidates who want to work in global regulatory submissions, dossier compilation, labeling activities, and product launch documentation. Lupin Hiring Freshers as Regulatory Affairs Officer
This detailed job post covers all essential information, including job role, responsibilities, qualifications, required skills, benefits, and step-by-step guidance on how to apply. The aim is to provide a complete understanding of the role while maintaining a search engine-friendly structure for improved visibility on job-related keywords. Lupin Hiring Freshers as Regulatory Affairs Officer
About Lupin Limited
Lupin Limited is one of the most respected names in the global pharmaceutical industry, with a strong portfolio in branded formulations, generics, biotechnology, and specialty products. Known for its high-quality manufacturing, research excellence, and international regulatory standards, Lupin continues to provide rewarding opportunities for candidates entering the pharma field. Lupin Hiring Freshers as Regulatory Affairs Officer
For freshers, especially those interested in documentation, regulatory submissions, and quality compliance, Lupin offers a professional environment to grow under expert guidance. The Regulatory Affairs team at Lupin supports global markets, ensuring that products meet regulatory requirements in regions like the United States, Europe, Australia, and emerging markets. Lupin Hiring Freshers as Regulatory Affairs Officer
Job Overview: Officer – Regulatory Affairs (Freshers Can Apply)
Job Role: Officer – Regulatory Affairs
Company: Lupin Limited
Work Location: Santacruz, Mumbai
Qualification: B.Pharm, M.Pharm, M.Sc (Chemistry or related field)
Experience: Fresher to 1 year
Job Type: Full-time
Application Mode: Online Application
Status: Verified Job
This position is designed for individuals who want to begin or expand their knowledge in RA and contribute to dossier preparation, information requests, and regulatory communication. Lupin Hiring Freshers as Regulatory Affairs Officer
Role Importance in Regulatory Affairs
Regulatory Affairs is one of the most crucial departments in the pharmaceutical sector. It ensures that all medicines manufactured by a company comply with the guidelines set by regulatory authorities such as USFDA, MHRA, TGA, EMA, WHO, and others. Lupin Hiring Freshers as Regulatory Affairs Officer
For freshers, RA provides a strong foundation in:
- Technical writing
- Regulatory documentation
- Product compliance
- Labeling and packaging review
- Understanding guidelines like ICH, FDA, EMA
- Quality systems and audit preparation
This role offers the chance to work closely with various cross-functional departments like Quality Assurance, Manufacturing, Analytical teams, Supply Chain, and Packaging Development.
Detailed Key Responsibilities
As an Officer – Regulatory Affairs at Lupin, you will handle responsibilities that directly impact global submissions and product life cycle management. The role requires attention to detail, accuracy, and the ability to handle regulatory documentation with precision. Key responsibilities include: Lupin Hiring Freshers as Regulatory Affairs Officer
1. Supporting Annual Report and Supplement Submissions
You will participate in preparing annual reports and submission supplements required by regulatory authorities. These reports ensure that all approved applications remain updated based on changes in formulations, processes, or packaging.
2. Assisting with New Product Launch Documentation
Collaborate with internal teams to gather technical and quality-related information required for launching new pharmaceutical products across different regulatory markets. This includes reviewing documents, preparing summaries, and ensuring compliance with regional guidelines. Lupin Hiring Freshers as Regulatory Affairs Officer
3. Preparing and Submitting Labeling Amendments
Work on label updates, packaging insert modifications, and changes requested by regulatory bodies. This includes understanding safety updates, warnings, dosage adjustments, and formatting requirements. Lupin Hiring Freshers as Regulatory Affairs Officer
4. Coordinating Responses to DRL (Discipline Review Letters) and IR (Information Requests)
During the product review stages, regulatory agencies send queries known as DRLs or IRs. Your role will involve compiling responses, coordinating with analytical and manufacturing teams, and ensuring that replies are submitted on time.
5. Supporting Complete Response Amendments
When a regulatory authority requests modifications or corrections, you will help prepare complete response packages. These amendments must be accurate and aligned with the agency’s expectations.
6. Cross-Functional Coordination
Work closely with internal teams to gather data, review documentation, and support regulatory strategies for new and existing products. Good communication and teamwork are essential for this requirement.
Educational Qualification Requirements
To be eligible for this role, candidates must meet the following educational criteria:
- B.Pharm or Graduation in Pharmacy
- M.Pharm (any specialization preferred for RA roles)
- M.Sc in Chemistry or any related scientific field
These qualifications ensure that the candidate has the scientific background required to understand regulatory guidelines and interpret data. Lupin Hiring Freshers as Regulatory Affairs Officer
Experience Requirements
- Freshers are eligible
- Candidates with up to 1 year of experience in Regulatory Affairs or quality documentation will be preferred
- Exposure to dossier compilation, CTD formats, and regulatory guidelines is beneficial
- Awareness of quality systems and good documentation practices is essential
Preferred Skills and Competencies
Candidates applying for this position must demonstrate strong soft skills and basic technical understanding. Lupin prefers individuals with: Lupin Hiring Freshers as Regulatory Affairs Officer
- Customer Centricity
- Strong Collaboration Skills
- Process Excellence
- Innovation and Creativity
- Strategic Agility
- Stakeholder Management
- Good Analytical and Problem-Solving Skills
- Strong Communication and Documentation Skills
- Willingness to Learn and Develop New Skills
These competencies ensure smooth coordination with teams, timely submissions, and effective involvement in regulatory processes. Lupin Hiring Freshers as Regulatory Affairs Officer
Why Choose a Regulatory Affairs Career at Lupin?
Lupin provides excellent career-building opportunities for candidates joining the RA department. Some key benefits include:
1. Exposure to Global Regulatory Processes
You will gain hands-on experience working on submissions for US, UK, EU, and other regulated markets.
2. Learning Opportunities with Experienced RA Teams
Experienced professionals will mentor and guide you, helping you grow quickly in this competitive sector.
3. Strong Career Development Path
Regulatory Affairs professionals are always in demand due to the increasing need for compliance and technical expertise.
4. Competitive Salary and Benefits
Lupin offers salary packages that match industry standards, along with medical coverage, leave benefits, and employee support programs.
5. A Secure and Reputable Work Environment
Working with one of India’s top companies provides long-term job stability and growth.
Job Location Details
The role is based in Santacruz, Mumbai, which is one of Lupin’s key corporate and research locations. The area offers excellent connectivity and is convenient for daily commuting. Lupin Hiring Freshers as Regulatory Affairs Officer
Who Should Apply for This Job?
This job is suitable for:
- Fresh B.Pharm or M.Pharm graduates
- M.Sc Chemistry graduates
- Candidates interested in documentation and regulatory systems
- Individuals looking for a stable and long-term career
- Candidates who want to work in international regulatory submissions
If you are a fresher looking for a strong career foundation in the pharmaceutical industry, this role provides the perfect stepping stone.
How to Apply for Lupin Regulatory Affairs Officer Job
Candidates interested in this role can submit their application online. Follow the steps below:
- Visit the official application link provided for this job.
- Register using your email ID and create a login.
- Fill in your personal and educational details accurately.
- Upload your updated resume in PDF format.
- Check all information carefully before submitting the form.
- Submit the application and note the reference number for future communication.
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