Jobs at Lupin | MSc Biotechnology Graduates Apply Now For The Executive Role
Lupin is hiring for the position of Executive at its Pune Biotech facility. This role offers an excellent opportunity for candidates with expertise in regulatory affairs, biosimilars, and pharmaceutical submissions. Suppose you are looking to build a career with one of the world’s leading global pharmaceutical companies. In that case, this position offers a dynamic environment in which to apply your skills in regulatory compliance and innovation.
- Job Position: Executive
- Location: Pune Biotech, RJ, IN
About the Company
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a strong presence in over 100 countries. Known for its high-quality generics, complex generics, specialty, and biotechnology products, Lupin is a trusted name in the healthcare industry. With a focus on innovation, regulatory excellence, and patient well-being, Lupin provides employees a platform to thrive in a collaborative and growth-driven environment.
Job Description
As an Executive at Lupin’s Pune Biotech facility, you will be responsible for preparing regulatory submission files across domestic, emerging, and regulated markets. The role involves handling queries from health authorities, reviewing GMP documents, preparing PAC applications, and managing other regulatory activities. You will coordinate with global business partners to ensure marketing authorization applications are submitted in compliance with evolving regulatory requirements.
Key Responsibilities
- Draft regulatory submission files for various markets.
- Handle and respond to queries from health authorities.
- Review GMP documents in accordance with regulatory standards.
- Prepare Post Approval Change (PAC) applications and oversee related regulatory activities.
- Coordinate with business partners for marketing authorization applications worldwide.
- Manage submissions on online portals for India, emerging, and regulated markets.
- Stay updated with regulatory requirements, especially for biosimilar products.
Qualifications
- Master’s in Biotechnology, Veterinary Science, Pharmacy, or Biopharmaceutics.
- 2 to 4 years of relevant experience in regulated markets.
- Strong knowledge of regulatory affairs and biosimilars (desirable).
- Excellent oral and written communication skills.
- Competencies in strategic agility, process excellence, stakeholder management, and innovation.
Keywords: Lupin, MSc Biotech, Executive position, Pune Biotech, RJ, IN, Pharmaceuticals, Regulatory affairs, Job Postings