Chemistry Job at Lupin | Officer – RA (API) Position in Santacruz
Are you looking for a Chemistry job that lets you contribute to innovation and regulatory excellence in the pharmaceutical industry? Lupin, a global leader in healthcare, is offering a rewarding Officer – RA (API) position in Santacruz, Maharashtra. This opportunity is part of Lupin Careers, inviting skilled professionals to manage regulatory submissions, DMF filings, and manufacturing documentation for markets such as the US and Europe. If you’re eager to grow your career in Regulatory Affairs and Manufacturing, this could be your next big step.
About Lupin
Lupin Limited is a globally respected pharmaceutical company headquartered in Mumbai, India. A leader in manufacturing and research, Lupin’s product portfolio spans key therapeutic areas including cardiovascular, diabetology, asthma, and anti-infectives. The company is known for its commitment to quality, innovation, and global regulatory compliance. Joining Lupin Careers means being part of a forward-thinking organization that values scientific excellence and continuous learning. Whether you are pursuing a career in Chemistry or a role in manufacturing and regulatory affairs, Lupin offers a platform for growth and professional success.
Job Details
- Job Title: Officer – RA (API)
- Location: Santacruz, MH, IN
- Work Experience: 2-3 Years in API Regulatory Affairs, DMF filing, and handling regulatory agency queries
- Education: Master’s in Chemistry
Job Description:
- Review of outsourced DMF and deal with suppliers for adequate data for ANDA/MAA/ ANDS filings.
- Responsible for arranging the documentation required for regulatory submissions to the US/Europe/ all other geographies – new DMF submissions, Amendments, and responses to Deficiencies.
- To provide Regulatory inputs during product development, manufacturing, and testing, and to evaluate all types of change proposals during the product life cycle.
- Responsible for evaluating the regulatory impact of the change notifications received from Outsource API vendors.
- Participate in the selection process of the supplier through audits from a regulatory compliance viewpoint for the new supplier & AVD.
Competencies:
- Customer Centricity
- Developing Talent
- Collaboration
- Strategic Agility
- Process Excellence
- Stakeholder Management
- Innovation & Creativity
- Result Orientation
