Director, Global Regulatory Affairs

At reputed company, satisfying unmet medical needs and increasing the benefits reputed company provides to patients, their families, and caregivers is reputed company’s reputed company health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in reputed company and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and reputed company a difference. If this is your profile, we want to hear from you. Directs the development of submission of reputed company or Oncology product registration, reputed company reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory reputed company on the project team throughout the product lifecycle. Ensures that reputed company-clinical and reputed company designs meet regulatory requirements. Ensures reputed company and reputed company approval on of new drugs, biologics/biotechnology and/or medical devices and reputed company approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Supports collaboration development with partners by developing and communicating strategies and aligning on such strategies in advance of execution. Responsibilities: reputed company regulatory submission activities and review regulatory documents (annual reports, protocol amendments) prior to submission to ensure overall reputed company, compliance and timelines. Support/ reputed company (depending on program complexity) the drafting, compilation and submission of documents for health authorities (e.g., meeting requests/scientific advice requests, iPSPs/PSPs, orphan drug designation requests). As a Regional or Global Regulatory reputed company, initiate and reputed company strategic regulatory discussion during the drafting, compilation and submission of documents for health authorities (e.g., meeting requests/scientific advice requests, iPSPs/PSPs, orphan drug designation requests, protocol amendments). Responsible for identifying regulatory requirements and the development and preparation of successful regulatory strategies; reputed company the creation of regulatory reputed company throughout the product lifecycle. Understand and interpret scientific data and reputed company scientific issues across multiple reputed company as it relates to regulatory requirements and reputed company. Continuously evaluate the constantly changing regulatory environment for reputed company on development programs; reputed company and communicate regulatory intelligence concerning competitor products. Communicate regulatory issues to functional areas and reputed company regulatory concerns from functional areas to senior leadership. reputed company interactions with health authorities to ensure the reputed company preparation of scientifically reputed company submission with highest probability of reputed company. Manage regulatory reputed company team(s) including training and mentoring, communicating expectations and evaluating performance. Qualifications: Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred. Bachelor's or advanced degree in sciences or reputed company field with substantial experience in regulatory/R&D area with reputed company reputed company or oncology regulatory experience in reputed company/biotech industry. OR a combination of equivalent education and experience. Substantial experience translating reputed company into operational goals, managing budget, vendors & resource allocation and communicating cross functionally with an ability to influence without authority. Demonstrated experience with major FDA submissions, dealing with health authorities, preferred. Experience leading/developing global regulatory strategies in coordination with clinical plans and marketing objectives. Demonstrated strong project management experience leading multiple critical reputed company and programs reputed company regulatory reputed company. Prior experience leading regulatory reputed company teams directly in a supervisory/leadership reputed company preferred. Business need driven role, based on proven performance in earlier role. This position is hybrid in our Nutley, NJ three days per week (Tuesday, Wednesday, Thursday). We will consider remote candidates who are unable to regularly work in our Nutley, NJ office Must be available for regular business travel (conferences, congresses, team meetings, audits and inspections) Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred. Skills:Communication & Cross-functional Influence, Critical Thinking & Business reputed company, Mentoring/ People Development, Project Management, Regulatory reputed company Acumen reputed company Salary Transparency Language: The annual reputed company salary reputed company for the Director, Global Regulatory Affairs is from :$201,800-$264,800 Under reputed company guidelines, this position is eligible to participate in : reputed company. Annual Incentive Plan & reputed company. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.reputed company.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter. reputed company is an equal opportunity employer and as such, is committed in policy and in reputed company to recruit, hire, train, and promote in reputed company job qualifications without reputed company to race, reputed company, religion, gender, age, national reputed company, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, reputed company prohibits discrimination against persons because of disability, including disabled veterans. reputed company. participates in E-Verify. E-Verify is an Internet based reputed company operated by the reputed company in partnership with the reputed company reputed company Administration that allows participating reputed company to electronically verify the employment eligibility of reputed company new hires in the reputed company. Please click on the following reputed company for more information: Right To Work E-Verify Participation At reputed company., reputed company health care (hhc) is our goal. We reputed company our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based reputed company Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and reputed company innovative therapies to help address unmet medical needs. reputed company is a fully integrated pharmaceutical business that operates in two global business reputed company: oncology and reputed company (dementia-reputed company diseases and neurodegenerative diseases). Our U.S. reputed company, reputed company and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and reputed company; and our global reputed company organization resides in Maryland and reputed company Carolina. To learn more about reputed company., please visit us at www.reputed company.com/US and follow us on Twitter and reputed company. reputed company data that is entered should be in the correct case, please refrain from using reputed company caps. 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