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 women’s 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 Fifteen 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.
ResponsibilitiesPurpose
The purpose of this role is to drive the strategic & business planning function for the US Generics business, through ongoing assessment and forecasting of key assets, help de-risk key assets, accelerate approvals for complex programs, assist with launch planning of these key assets, and lead integrated efforts for assuring the delivery of the strategic plan for the US Generics business.
Role and Responsibilities
Lead strategic transactions for the Company, including leading negotiations for corporate M&A and complex licensing and collaboration transactionsStructure, draft, and negotiate complex transactional agreements related to the sameManage internal and external deal processes and drive deal execution (including form documentation)Plan, assist, and coordinate due diligence exercises as needed. The majority of transactions will focus on the United States market; however, the targeted geographies include Canada, Europe, Mexico, Brazil and other Latin American countriesLed the drafting of general corporate contracts – drafting, negotiating, and reviewing a wide variety of corporate contracts, including confidentiality, consulting, services, manufacturing, clinical trial, basic licensing, and related agreementsWork closely with Business Development, Finance/Accounting, Commercial, and Specialty Businesses to assist in their day-to-day operations/functionsResearch, report and recommend corporate actions based on applicable laws and regulations affecting company projects, deployments, business development, accounting, tax, facilities, and administration.Review and revise company policies and procedures as required by applicable law and regulations, and internal requirementsSupport Senior Vice President – Legal Affairs in other tasks, including review and negotiation of lender and other strategic agreements.Advise senior management and business personnel, as requiredAssist with regulatory and other legal pharmaceutical compliance matters, as requiredManage outside advisors, including active management of outside counselScope and Size
Direct reports: NoneGeographic coverage: USSuccess Metrics
Feedback from key business stakeholders in Technical, Regulatory, and Commercial teams Timely approval of key assets / complex products Successful launch of key assets – timelines, sales, etc.Quality of support provided towards business developmentStakeholder Network
Internal: R&D teams (Americas and EMEA), Commercial, Regulatory, Supply chain, Somerset site leadership team, etc.External: Customers (Retail chains, Wholesalers, GPOs / Hospitals, etc.), R&D consultants, Business partners, FDA, etc. QualificationsQualifications, Education, and Skill Requirements
JD degree from an ABA-accredited law school with strong academic credentials.BA/BS from an accredited institutionTen years of law firm and/or in-house, pharmaceutical legal experienceMember of at least one state barCandidates must be able to demonstrate a robust understanding of pharmaceutical business transactions and regulatory issues, intellectual property law, licensing, and mergers and acquisitions.Will be responsible for leading in-licensing, out-licensing, and acquisitions of the companyExperience and familiarity with foreign jurisdictions, especially Europe, is a plus.Awareness of Federal and State healthcare laws and regulations, including Medicare, Anti-kickback, AntitrustExcellent communication skills (both verbal and written)History of self-motivation, sound judgment, and excellent interpersonal relationsThe position requires initiative, responsibility, creativity, motivation, flexibility, and the ability to work independently with minimal supervisionExperience with drafting and negotiating M&A documents, commercial contracts, and pharmaceutical licensing agreementsAbility to communicate effectively with a variety of constituents including executive management, company associates, outside counsel, outside organizations, and agenciesDemonstrate broad business orientation and ability to quickly establish credibility as an attorney and business partner with a cross-functional perspectiveResponsiveness and adaptabilityIntegrity and strong ethicsAbility to travel periodically as neededWillingness and interest in learning and continuing to develop one’s career and skills
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, veteran’s status, or any other classification as required by applicable law.
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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, veteran's status, or any other classification as required by applicable law.