Executive Regulatory Affairs Job at Lupin in Airoli Mumbai for regulatory affairs professionals with Europe dossier experience and pharma qualifications.
About the Company
Lupin is one of India’s leading multinational pharmaceutical companies with a strong global presence across regulated and emerging markets. Established with a vision to deliver affordable and high-quality medicines, Lupin has built a robust portfolio spanning generics, branded generics, complex products, APIs, and specialty pharmaceuticals.
The company is widely respected for its strong compliance culture, innovation-driven approach, and consistent focus on regulatory excellence. Lupin’s regulatory affairs teams play a critical role in ensuring timely approvals, lifecycle management, and global market access for products across Europe, Australia, Canada, New Zealand, and other regulated regions. Working at Lupin means being part of an organization that values ethics, quality, employee development, and long-term career growth. Executive Regulatory Affairs Job at Lupin
Job Details
- Job Title: Executive – Regulatory Affairs (RA)
- Company: Lupin
- Location: Airoli, Mumbai, Maharashtra, India
- Department: Regulatory Affairs
- Employment Type: Full-time
- Experience Required: 2–4 years (Fresh M.Pharm candidates can also apply)
- Education: B.Pharm / M.Pharm
This opportunity is ideal for regulatory affairs professionals who want to strengthen their exposure to global markets and gain hands-on experience with eCTD dossiers, agency queries, and lifecycle management of registered products. Executive Regulatory Affairs Job at Lupin
Job Description
The Executive – Regulatory Affairs role at Lupin is designed for professionals who are passionate about regulatory compliance and global submissions. The selected candidate will be responsible for preparing and managing regulatory dossiers for regulated markets, responding to health authority queries, and coordinating with cross-functional teams to ensure smooth product registrations and post-approval changes. Executive Regulatory Affairs Job at Lupin
This role requires a strong understanding of international regulatory guidelines, excellent documentation skills, and the ability to manage multiple submissions within defined timelines. Candidates will work closely with internal stakeholders such as R&D, QA, QC, manufacturing, and external regulatory agencies to support the complete lifecycle of pharmaceutical products. Executive Regulatory Affairs Job at Lupin
Key Responsibilities
- Preparation, compilation, and review of regulatory dossiers for Europe, Australia, Canada, and New Zealand markets.
- Development and submission of high-quality eCTD dossiers in line with regional regulatory requirements.
- Drafting accurate, timely, and scientifically sound responses to regulatory agency queries and deficiency letters.
- Review of proposed changes received from cross-functional teams and identification of regulatory variation requirements.
- Coordination with internal departments to collect, review, and finalize documents required for submissions.
- Lifecycle management of registered products, including renewals, variations, amendments, and post-approval changes.
- Ensuring compliance with applicable regulatory guidelines, company SOPs, and quality standards.
- Tracking submission timelines, approvals, and commitments to ensure on-time regulatory deliverables.
- Supporting audits, inspections, and internal regulatory reviews as required.
- Maintaining up-to-date regulatory documentation and databases.
Executive Regulatory Affairs Job at Lupin
Skills/Qualifications
Educational Qualifications
- Bachelor’s degree in Pharmacy (B.Pharm) or Master’s degree in Pharmacy (M.Pharm).
- M.Pharm freshers with strong regulatory knowledge and internship exposure are encouraged to apply.
Experience
- 2 to 4 years of hands-on experience in Regulatory Affairs for B.Pharm or M.Pharm candidates.
- Exposure to regulated market submissions such as Europe, Australia, Canada, or New Zealand is highly desirable.
Technical Skills
- Strong understanding of regulatory guidelines for EU, Australia, Canada, and New Zealand markets.
- Practical knowledge of eCTD dossier preparation and submission processes.
- Familiarity with lifecycle management, variations, and post-approval changes.
- Good documentation practices and attention to detail.
Executive Regulatory Affairs Job at Lupin
Behavioral and Functional Competencies
- Strategic agility to adapt to evolving regulatory requirements.
- Process excellence with a structured and compliant approach to submissions.
- Strong collaboration skills to work effectively with cross-functional teams.
- Innovation and creativity in problem-solving regulatory challenges.
- Result orientation with the ability to meet strict timelines.
- Stakeholder management skills to coordinate with internal and external partners.
- Customer-centric mindset focused on quality and compliance.
- Interest in developing talent and continuous learning.
Executive Regulatory Affairs Job at Lupin
Benefits/Perks
Lupin offers a comprehensive and competitive benefits package designed to support both professional and personal growth:
- Competitive salary aligned with industry standards.
- Exposure to global regulatory markets and complex submissions.
- Structured training and development programs for skill enhancement.
- Opportunities for career growth within regulatory affairs and related domains.
- Professional work environment with a strong compliance and quality culture.
- Health insurance and other statutory benefits as per company policy.
- Collaborative and inclusive workplace that values innovation and integrity.
Executive Regulatory Affairs Job at Lupin
Why You Should Join
Joining Lupin as an Executive – Regulatory Affairs provides an excellent platform to build a long-term career in one of the most critical functions of the pharmaceutical industry. This role offers exposure to highly regulated international markets, allowing professionals to enhance their regulatory expertise and global understanding.
Lupin’s emphasis on ethics, compliance, and employee development ensures that individuals are not only challenged professionally but also supported in their growth journey. Whether you are an experienced RA professional or an M.Pharm fresher eager to start your regulatory career, this position offers valuable learning, stability, and advancement opportunities. Executive Regulatory Affairs Job at Lupin
How to Apply
FAQs
Q1. Is this position suitable for freshers?
Yes, M.Pharm freshers with strong regulatory knowledge and interest in global submissions can apply.
Q2. What markets will the candidate work on?
The role primarily focuses on Europe, Australia, Canada, and New Zealand markets.
Q3. Is eCTD experience mandatory?
Hands-on experience with eCTD is preferred, but candidates with strong regulatory fundamentals may also be considered.
Q4. Where is the job location?
The position is based in Airoli, Mumbai, Maharashtra.
Q5. What is the required experience for B.Pharm candidates?
B.Pharm candidates should have 2–4 years of relevant regulatory affairs experience.
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