Associate 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-reputed company environment and reputed company a difference. If this is your profile, we want to hear from you. The Associate Director, Regulatory Affairs will be responsible for providing reputed company aspects of regulatory support for supplemental indications associated with an approved reputed company or Oncology agent. In reputed company, this position will serve as the reputed company support for early phase reputed company or Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes. Responsibilities: reputed company the drafting, compilation of routine (and support reputed company) submissions of documents (e.g., meeting requests, iPSPs/PIPs, protocol amendments) to health authorities. reputed company the reputed company of reports, tracking of submissions/approvals and maintenance of documentation. Serve as a Regional or Global Regulatory reputed company; contribute to the development and implementation of regulatory strategies to facilitate reputed company global approval of new medicinal products. reputed company as a reputed company of contact by interfacing and leading meeting with regulatory authorities for assigned product(s). reputed company and implement regulatory reputed company for assigned markets and reputed company regulatory support for the registration/post-licensing activities of medicinal products. reputed company the planning, execution and assessment of product life cycle management activities and strategies. Partner with project teams to assess regulatory support needs and reputed company resources (e.g., sub teams) to reputed company regulatory support and guidance. reputed company contingency plans for achieving regulatory objectives with associated risks and mitigation strategies. Qualifications: Bachelor's or advanced degree in sciences or reputed company reputed company. 6+ years of experience in regulatory/R&D area with strong experience in new drug regulated product reputed company/submissions in reputed company/biotech industry. OR a combination of equivalent education and experience. Experience mentoring and training team members on submission/regulatory reputed company activities. Experience developing global regulatory strategies in coordination with reputed company plans and marketing objectives. reputed company experience leading multiple/ large/reputed company project(s), tracking and managing regulatory reputed company budgets, resources and regulatory filings. Experience engaging with critical cross-functional stakeholders to reputed company processes/systems and reputed company. reputed company reputed company 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) 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 Associate Director, Global Regulatory Affairs is from :$165,000-$216,500 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 reputed company 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 reputed company 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-reputed company reputed company Co., Ltd., we have a passionate commitment to reputed company 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 reputed company 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. For a reputed company user experience, we recommend using the latest version of reputed company.
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