Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on womens health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Role and Responsibilities:

• Creation and Maintenance of Drug product labeling including track of RLD labeling updates, SPL creation, Drug listing
• Compilation/publishing of eCTD correspondences
• Preparation and submission of Labeling Supplements, Annual Reports, Quarterly and Annual periodic adverse drug experience reports, etc.
• Collect, organize and review the required documentation to be included in annual reports, supplements
• Submit electronic correspondences through the Gateway; track the submitted correspondences, run a daily/monthly report of all submissions, co-ordinate with overseas counterparts for submission timelines.
• Responsible for maintaining and updating various regulatory databases to ensure accuracy of information.

• Archive and maintain regulatory documentation (paper or electronic) in accordance with applicable regulatory requirements and the companys established practices and procedures.
• Facilitate applicable user fees (GDUFA/PDUFA/BSUFA) and coordination with stakeholders to ensure timely payment of applicable fees.
• Support various departments such as sales and marketing, customer service, logistics, legal, IP, pipeline teams with all requested information/queries.
• Support with state manufacture/distribution licenses activities.
• Assist in the development of departmental SOPs as required.
• Any additional responsibilities as assigned by hiring manager.
• Ability to work with multiple top priorities, and requests from other teams
• Advanced computer skills & ability to conduct research through the internet
• Strong organizational skills with the ability to keep others organized and meet all deadlines

• Bachelor or Masters Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred)
• 2-3 years experience in the pharmaceutical industry with 1-2 of those years in regulatory affairs preferred

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veterans status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Search Firm Representatives Please Read Carefully

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails

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