Regulatory Affairs Officer – Lupin, Mumbai
Are you ready to launch your career in Regulatory Affairs with a leading pharmaceutical company?
Lupin is seeking a motivated and detail-oriented Regulatory Affairs Officer to join our team in Santacruz, Mumbai. This is an excellent opportunity for a recent graduate or early-career professional to gain valuable experience in the pharmaceutical industry and contribute to global regulatory submissions.
About Lupin:
Lupin is a global pharmaceutical company committed to delivering high-quality, affordable medications to patients worldwide. We are driven by innovation and dedicated to improving healthcare outcomes.
Key Responsibilities:
As a Regulatory Affairs Officer, you will contribute to:
- Preparing and submitting annual reports and supplements.
- Supporting new product launch documentation.
- Preparing and submitting labeling amendments.
- Coordinating responses to Discipline Review Letters (DRL) and Information Requests (IR).
- Assisting with Complete Response Amendments.
- Collaborating with cross-functional departments to support regulatory strategies.
Qualifications:
- Education:
- B.Pharm / Graduation in Pharmacy
- OR M.Sc / Masters in Chemistry
- Experience:
- Fresh graduate to 1 year of experience in Regulatory Affairs.
- Awareness of quality guidelines and dossier compilation.
Preferred Competencies:
- Customer Centricity
- Strong Collaboration Skills
- Innovation & Creativity
- Process Excellence
- Result Orientation
- Strategic Agility
- Stakeholder Management
- Willingness to learn and grow
Why Join Lupin?
- Exposure to international regulatory processes.
- Learning opportunities with experienced RA teams.
- Career development in a globally recognized pharmaceutical company.
- Competitive salary and employee benefits.
How to Apply:
Interested candidates are encouraged to apply through the Lupin careers website.