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Director, Global Team Member Regulatory Affairs Product Group

Description:                                                                 Seasoned regulatory professional who has demonstrated effective leadership and in-depth expertise for a broad range of global regulatory and drug development topics so as to successfully manage complex projects and/or sensitive topics.   For assigned development projects/products, provide strategic global regulatory expertise to the Core Team and other discipline's respective sub teams, challenge development/PMO programs scientifically and  manage all global regulatory aspects through the development of new medicinal products, new indications or PMO projects as well as the maintenance period; be accountable for the global development of investigational projects (including complex projects) towards submission, approval, and coordination of regulatory maintenance activities taking into account and being compliant to respective drug laws.    Effectively lead the regulatory sub teams of global drug or device projects, potentially with the involvement of licensing partners, representing Global Regulatory Affairs in the Core Team of a project and project related sub teams (e.g. PVWG) and provide global leadership and strategic planning to ensure sound regulatory practices are integrated into international drug development programs for assigned NCE/NBEs or PMO projects.   Maintain current expertise and adhere to regulatory standards, provide analysis, advise on and implement regulatory strategies and departmental policies and utilize resources consistent with the overall goals and objectives of the GRA department.  Recognized expertise on developments in the assigned therapeutic area from the global regulatory, scientific, and pharmaceutical, pharmacovigilance, market access and commercial perspective.   As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees   Duties & Responsibilities: Regulatory Professionalism - Recognized regulatory expert with demonstrated global strategic expertise in one or more therapeutic areas, interact effectively at all levels of the organization, within Regulatory Affairs and across functions, as an influential advocate to achieve common goals for assigned projects.  RA Sub teams - Demonstrated proficiency in leading RA Sub teams. Convey up-to-date project information to ensure sub team members can fulfill their assigned tasks as well as seek input from RA sub team functions to accurately reflect global regulatory requirements and challenges in the Core Team. Generation and alignment within RA sub team of RSUs, ORION meeting content and timings, management briefings (PURs) as well as pre-reads and presentation at the Regulatory Expert Group (REG). Responsible for the GRA contribution to all project related documentation such as the management summary, TALC / HPSC / DC pre-reads. - Demonstrated proficiency in leading RA Sub teams. Convey up-to-date project information to ensure sub team members can fulfill their assigned tasks as well as seek input from RA sub team functions to accurately reflect global regulatory requirements and challenges in the Core Team. Generation and alignment within RA sub team of RSUs, ORION meeting content and timings, management briefings (PURs) as well as pre-reads and presentation at the Regulatory Expert Group (REG). Responsible for the GRA contribution to all project related documentation such as the management summary, TALC / HPSC / DC pre-reads. Global Regulatory Strategy - Demonstrated proficiency to independently lead the RA sub team to develop and implement a sound global regulatory strategy, including for complex projects. Recognized expertise for presenting and assessing strategic options and providing regulatory advice to support assigned development projects and Product Maintenance Optimization strategies taking into account the global goals and the regional requirements considering, where appropriate, expedited regulatory pathways. Lead generation of a Global Regulatory Strategy document and coordinate the input from RA sub team members as well as ensure GRS endorsement by appropriate GRA functions/bodies. External/internal assessments, external partners - Provide experienced global regulatory leadership to Participate and support internal and external pre-evaluations (e.g. Due Diligence), including for complex projects.  Identify and effectively communicate   global regulatory strategic considerations to assessment reports. For projects with a licensing partner fulfill global RA tasks (e.g. chair of regulatory teams etc.) as outlined in the licensing contract HA Meetings - For assigned projects, provide experienced global regulatory leadership to establish global strategy and goals for formal meetings with health authorities, aligned with Core Team as well as RA Sub team, and adjusted during the course of development as needed. Support the respective sTM RA(s) in defining region-specific questions and content in advance of HA meetings. In collaboration with the respective TM RA, provide guidance and input to various types of health authority meetings, including preparation of briefing documentation (e.g. scientific advice, EoP II, pre-submission meetings) as well as planning the actual meeting. Attend health authority meetings for assigned projects as appropriate. General global regulatory considerations - Demonstrated proficiency to consistently provide sound global strategic regulatory guidance and input to key global development, registration and commercialization documents for assigned projects, including complex projects (e.g. development plans, protocols, clinical trial reports, CTAs, pediatric development plans  and applications, core dossier elements, integrated brand plans, market access documents, with particular emphasis to company's overall hyper focus and focus country prioritization.)   In cooperation with Global Labelling , provide strategic project-related global regulatory leadership into content of the draft CCDS taking into account sound knowledge of global TA labeling precedence/guidance's for key claims ; support sTM RAs in regional/local discussions related to the content of drug  labelling (e.g. EU SmPC and US PI),  during development, submission preparation, submission review and product lifecycle. Demonstrated proficiency in providing sound global regulatory leadership in the preparation, content and distribution of critical safety or quality communications for assigned projects following internal procedures and coordinating simultaneous and content harmonized communications to HAs in conjunction with TM Medicine, ECs/IRBs and investigators. For marketed products, provide global regulatory leadership and guidance in resulting communications to Health Care providers, e.g. through DHCPs. Maintain global oversight of local RA activities in response to local health authority questions regarding assigned projects. Provide global regulatory guidance and input to regulatory submissions (e.g. MAAs/NDAs/BLAs, Extensions, CTAs, Variations/supplements, PIPs/PSPs, labelling) as appropriate. Support submission rollout for RoW countries from the global strategic perspective with particular emphasis on BI country prioritizations. Demonstrated expertise in reviewing and releasing via cross-functional medical-legal-regulatory team global core promotional messages as defined by respective BI processes. Regulatory Intelligence - Recognized internal expertise for regulatory intelligence relate to assigned projects. Proactively and critically evaluate relevant global regulations and guidelines, as well as evolving regulatory trends and developments, for their impact on drug development activities and on existing development strategies. Develop and advise on contingency plans for assigned projects as necessary. Provide robust and timely global regulatory assessments of issues affecting products/projects through continuous monitoring of available regulatory and competitor information. Internal regulatory topic lead or participant in cross-functional working groups to represent GRA, as appropriate Mentoring - Based on internally recognized regulatory expertise, formally and informally mentor other TM RAs.  Mentor other GRA functions including RA sub team members and provide education to pharmacy students. Requirements: Minimum requirement: Bachelor's degree from an accredited institution in pharmacy, life sciences or chemistry Preferred requirement: Master's Degree or Doctoral Degree (e.g. PhD) from an accredited institution in pharmacy, life sciences or chemistry. Preferred: Additional degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification Ten (10) years' experience in regulated pharmaceutical industry In-depth knowledge in RA gained through direct regulatory liaison in at least one major region and experience in RA requirements/tasks in at least two regions, preferably one of them EU or US. "Fluent" medical, pharmaceutical and scientific knowledge and understanding preferably in the assigned therapeutic area Senior TM RA will represent GRA in the Core Team as the globally responsible person. As such understands the processes and procedures within GRA as well as the global regulatory requirements to be able to represent GRA in the Core Teams/other cross functional teams. TM RA expertly leads the regulatory sub team to ensure definition and implementation of sound regulatory strategies throughout development and post-approval. May serve in the capacity of local (US) Regulatory Area Lead (RAL) see specific profile for additional responsibilities associated with this function Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older 181724
Salary Range: NA
Minimum Qualification
8 - 10 years

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