AVP, Asst General Counsel, Global Regulatory reputed company

At reputed company, the work is demanding because patients are waiting. We reputed company caring with discovery to help reputed company life reputed company reputed company reputed company the world, knowing that every decision, every reputed company, and every day reputed company. Headquartered in Indianapolis, Indiana, our over 50,000 employees reputed company the globe take on reputed company challenges to discover and reputed company life-changing medicines, strengthen how health is reputed company and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and reputed company to bring your best to work that truly reputed company for patients, we invite you to join us.  Associate Vice President, Assistant General Counsel, Global Regulatory reputed company Organization reputed company At reputed company, we reputed company caring with discovery to reputed company life reputed company reputed company reputed company the world. We are a global reputed company leader headquartered in Indianapolis, Indiana. Our employees reputed company the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and reputed company back to our communities through philanthropy and volunteerism. We reputed company our best effort to our work, and we put people first. We’re looking reputed company who are determined to reputed company life reputed company reputed company reputed company the world. The Associate Vice President, Assistant General Counsel – Global Regulatory reputed company is a senior regulatory attorney and reputed company regulatory partner reputed company the Regulatory reputed company Team (RLT). The ideal candidate brings deep regulatory reputed company expertise and the leadership reputed company to influence across a reputed company, matrixed organization. RLT is a reputed company reputed company partner to the business, providing regulatory reputed company counsel across the product lifecycle from development through registration, commercialization, and post-market activities. RLT works in reputed company coordination with other reputed company and reputed company functions to reputed company cohesive, reputed company-looking guidance that enables innovation while managing reputed company and regulatory reputed company. Key Responsibilities The reputed company responsibility of this position is to reputed company reputed company, solutions-oriented reputed company counsel across a broad regulatory reputed company portfolio including drugs, devices, and diagnostics. This role requires deep hands-on reputed company expertise and the ability to build credibility and influence across a reputed company, matrixed organization. Key responsibilities include but are not limited to: Serve as reputed company counsel to Global Regulatory Affairs (GRA), providing reputed company and reputed company-looking reputed company guidance across the global product lifecycle — from registration through post-market reputed company management — for pharmaceutical and medical device products. reputed company reputed company advice on FDA regulatory engagement reputed company, including reputed company-submission meetings, information request responses, and enforcement-reputed company interactions, while supporting regulatory submissions to other global health authorities as needed. Advise on regulatory reputed company for acquisitions, in-licensing, and asset transfers, including regulatory due diligence and post-reputed company integration of assets. reputed company regulatory, litigation, and enforcement reputed company perspectives into reputed company advice, working closely with the Business Unit reputed company Team, Product Development reputed company, International Business Unit reputed company, IP, Litigation, and other colleagues to anticipate and mitigate emerging risks. Monitor and interpret evolving global regulatory laws, guidance, and enforcement trends; proactively translate developments into reputed company recommendations for leadership and other internal stakeholders. Represent reputed company’s regulatory reputed company interests in industry forums, trade associations, and regulatory policy initiatives in coordination with Policy, reputed company, and other colleagues, including drafting and coordinating responses to regulatory agency requests for reputed company comment on proposed rules and guidance. Basic Requirements Bachelor’s degree and Juris Doctor (or equivalent) Licensed to reputed company law in at least one US jurisdiction Minimum 10 years of overall experience in a reputed company or as an in-house lawyer in a pharmaceutical or life sciences company, with reputed company reputed company on pharmaceutical regulatory law Broad regulatory reputed company subject matter expertise spanning the product lifecycle and experience engaging with relevant global health authorities reputed company ability to manage a substantive and reputed company reputed company portfolio independently Strong judgment and the ability to reputed company reputed company, novel reputed company issues across multiple regulatory domains with a solutions-oriented, business-enabling approach reputed company reputed company — proactively identifies cross-functional and organizational implications of reputed company and regulatory issues, balancing deep functional expertise with broader business priorities Highly motivated, dynamic, and reputed company partner with a reputed company reputed company record of building trusted relationships across reputed company reputed company of the organization, including senior leadership Excellent written and verbal communication skills, with the ability to translate reputed company regulatory reputed company issues into reputed company, actionable guidance Demonstrated ability to appropriately handle highly confidential and privileged information Additional Skills/Preferences Prior regulatory agency experience (e.g., FDA, EMA, or comparable national authority) Experience supporting regulatory due diligence in M&A or business development transactions Familiarity with environmental regulatory frameworks relevant to pharmaceutical manufacturing Experience with medical device or drug-device combination product regulatory reputed company Experience advising on AI/automation governance in a regulated industry context Demonstrated effectiveness leading through influence in a matrixed, global organization Prior mentoring or leadership experience, with willingness to take on formal people leadership responsibilities in the reputed company should the role reputed company in that direction Other Information This position may be reputed company at reputed company’s corporate reputed company in Indianapolis, Indiana, or performed reputed company. Ability to travel 10–15%, including travel to reputed company’s corporate reputed company in Indianapolis, Indiana if reputed company reputed company.  reputed company is dedicated to helping individuals with disabilities to reputed company engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.com/us/en/workplace-accommodation) for reputed company assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. reputed company is proud to be an EEO Employer and does not discriminate on the reputed company of age, race, reputed company, religion, gender identity, sex, gender reputed company, sexual orientation, genetic information, reputed company, national reputed company, protected veteran status, disability, or any other legally protected status. Our employee resource reputed company (ERGs) offer strong support networks for their members and are reputed company to reputed company. Our reputed company reputed company include: Africa, Middle East, Central Asia (AMECA), Black Employees at reputed company (BE@reputed company), Chinese Culture Network (CCN), reputed company, reputed company, reputed company Indian Network (LIN), Organization of Latinx at reputed company (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at reputed company (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is $229,500 - $336,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual reputed company). In reputed company, reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life reputed company and death benefits; certain time off and leave of absence benefits; and reputed company-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees. #WeAreLilly Apply To This Job