Lupin Pharmaceuticals, Inc.
Director, Regulatory Affairs (Biotech)
Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and Commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin's U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our harbor side location in Baltimore, Maryland. Adding to Lupin's U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin's Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.
Summary:
This person will act as a liaison between the RA of LPI and RA and R&D of Lupin Ltd., review the ANDAs pre or post-submission and proactively work with Lupin Ltd. or other branches of Lupin to resolve any outstanding issues that are identified - to support a quicker approval of the applications. The candidate will also eventually get involved in the early stages of product development to assure that the ANDAs with good experience in Complex Products, have sufficient information to support a quicker approval. This person should also have knowledge related to 505b(2) submissions. The person should have a MS or PhD with minimum of 10+ years' experience in Pharmaceutical Development and knowledge of FDA's current requirements related to strategies and submissions.
This position supervises Regulatory personnel as required. Further, it supports all the Regulatory aspects of the Company's generic businesses.
Essential Duties and Responsibilities
• Responsible for the coordination/review (all critical) documents for submission to US regulatory authorities including; new ANDAs/DMFs as well as the preparation of supplemental applications and amendments.
• Under the direction of the Senior Vice President of Regulatory Affairs is an essential point of contact/liaison with FDA and related health authorities where applicable. Responsible for establishing productive working relationships with the US Regulatory authorities providing guidance to the company by addressing specific issues and information requests.
• Responsible to establish and continue of maintaining the engagement with cross-functions to complete the tasks.
• Responsible for the maintenance and providing post-marketing support of ANDAs/DMFs to remain current with all applicable laws, regulations, guidance's, etc. and assure that the post-marketing reports are submitted within required timeframes.
• Responsible for preparation of information and related activities for meetings with drug regulatory agencies as well conduct of meeting and preparation of accurate meeting minutes
• Provides support for due diligence activities associated with business development as required
• Maintains a detailed knowledge of FDA regulations, guidelines and standard procedures
• Responsible for the preparation of periodic (monthly, quarterly, annual) progress reports as required.
• Supervise assigned Regulatory staff and conduct to ensure periodic performance evaluation in accord with organizational structure
• Responsible for overseeing departmental databases such as list of approved products, currently manufactured products, approved manufacturers and suppliers of active ingredient, tracking systems for submissions status as well as periodic departmental reports.
• Perform other duties as assigned.
• MS or PhD in physical, pharmaceutical, biological or other life science plus direct FDA submission experience. Advanced degree a plus.
• A minimum of 12 years of hands-on regulatory experience, with 5 years in a management role. Further, 8-10 years of experience with a successful record of submissions and approvals of ANDA applications to the FDA.
• A history of interaction with the OGD Divisions of the FDA as well.
• Experience with complex generics products such as Injectable, Dermatological, Ophthalmic, respiratory product/devices for US.
• Excellent written and verbal communication, presentation skills are required.
• Good interpersonal skills and experience to working with cross-functional, multinational teams.
• Strong team management and developing skill set.