Sr Director, Regulatory & Public Policy - Washington DC
: Job Details :

Description:The Senior Director – Policy will lead on the ground development and advocacy for Amneal's positions on policies proposed and/or enacted by Congress, the Centers for Medicare and Medicaid (CMS), the U.S. Food and Drug Administration, and other federal and state government entities. These matters routinely involve highly complex and specialized topics that directly impact Amneal's research and development, commercial, legal, and finance work functions. Consulting with subject-matter experts and company leadership across these work functions, the Senior Director will be responsible for soliciting, collating, drafting, and communicating Amneal's positions on policies directly to federal agencies and Congressional offices, including comments on FDA and CMS guidances and regulations, as well as policies on the state level. This person also will represent Amneal on relevant policy-focused committees of trade associations and with other public-facing bodies. In addition to this policy development work, this position will offer regulatory policy counsel on specific topics or product projects related to drug development that require internal consultation and regulatory research to support the above-listed work functions, and actively will contribute to Amneal's ongoing reputation-building effort. This person also will support Amneal's Government Procurement function on company commercial priorities.Essential Functions:Lead development of Amneal's position respect to FDA, CMS, Congressional, and state policy proposals reflected in proposed legislation, regulations, guidances, and other policy statements through solicitation from Amneal subject-matter experts and leadership, comment drafting, and advocacy on policies impacting R&D, commercial, finance, and legal work functions in Generics, Specialty, and Biosimilars.Provide expert counsel to R&D, Generic, Specialty, and Legal workstreams on specific R&D, regulatory, or reimbursement matters.Effectively advocate for Amneal policy positions through representation on scientific, regulatory, and reimbursement committees for trade associations and other publicly facing organizations.Closely monitor FDA, CMS, FTC, and state regulatory actions and activities that would impact the company's operations and/or business goals; make appropriate recommendations for action to company leaders; inform relevant Amneal employees; develop and implement standardization of information dissemination process.Collaborate with other members of management to help ensure that all efforts the company undertakes are coordinated and complementarySupport development and implementation of strategy to enhance Amneal reputation with regulators and other government entities, which should include becoming well-versed in Amneal's patient, industry and value to customers and patients, and identifying and leveraging relationships with ally groups.Support Government Procurement function on federal and state levels on policy priorities and on specific commercial priorities.Education:Juris Doctor JD - PreferredMaster Degree (MS/MA) MPH - PreferredExperience:10 years or more in Experience with policy development and advocacy in the pharmaceutical regulatory or payment contexts.4 years or more in Senior level government experience is preferred.Skills:Engage with subject matter experts and senior leadership to identify, develop, and draft Amneal policy positions. - AdvancedAdvocate for Amneal policy priorities with trade associations and policy makers - AdvancedDevelop subject-matter expertise on complex issues related to pharmaceutical development and/or marketplace - AdvancedSpecialized Knowledge:Knowledge of pharmaceutical sector and pharmaceutical policy.Knowledge of FDA and/or CMS regulatory systems.Licenses:JD-Upon Hire-PreferredUpon HireFull timePosting Date: 2024-07-22