Senior Director, Global Regulatory Affairs, Neurology

Eisai US; Nutley (NJ); On-site; USD 249,000 - 327,000; Full time

Job summary

Eisai Inc. is seeking a Senior Director, Global Regulatory Affairs, Neurology, to lead regulatory strategy for the global neurology/oncology portfolio.

This role oversees submissions, milestones, and clinical strategies, engaging with health authorities and cross-functional teams in a fast-paced environment from Nutley, NJ with hybrid work options. The Senior Director will manage regulatory strategies, budgets, vendor relations, and cross-functional collaborations to meet business goals while

Qualifications

• Bachelor's degree (Master's preferred) and 12+ years of relevant experience.
• Experience in Life Sciences industry preferred.
• Bachelor's or advanced degree in sciences or related field with significant regulatory/R&D experience.
• Experience interfacing with FDA and international health authorities; knowledge of FDA laws and guidances.

Responsibilities

• Function as a Regional or Global Regulatory strategy lead for regulatory submission activities.
• Lead strategic regulatory discussions and drafting documents for health authorities.
• Identify, develop and implement regulatory strategies for global portfolios.
• Lead regulatory activities with emphasis on strategy and document preparation for health authorities.
• Drive execution of Eisai's regulatory strategies through scientific, regulatory, and business insights.
• Identify strategic opportunities and threats; ensure resources to mitigate risks.
• Direct budgeting, vendor management, timelines, and resource planning for regulatory programs.
• Lead initiatives to improve regulatory strategy processes and systems with key stakeholders.
• Ensure clear deliverables, proper communication, and accountability within teams.
• Direct people management including goal setting, performance management, and development.

Skills

Communication

Cross-functional Influence

Critical Thinking

Business Agility

Mentoring/People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's degree (Master's preferred)

Job description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology 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 make a difference. If this is your profile, we want to hear from you.

The Senior Director, Global Regulatory Affairs, Neurology will identify and implement company regulatory strategies for the global Neurology or Oncology portfolio as well as standards in alignment with short and long term business plans. Using a hands on approach, this position will ensure the completion of all goals and objectives related to regulatory submissions and milestones, and clinical strategies and trials. The Senior Director is responsible for leading the activities of Regulatory Affairs with emphasis on regulatory strategy and the preparation, review and evaluation of documents for FDA, EMEA, and PMDA submission. The Senior Director participates on committees (internal and external), in health authority interactions, and in organizational decision making processes where appropriate.

Responsibilities:

• Function as a Regional or Global Regulatory strategy lead and oversee regulatory submission activities and review regulatory documents (e.g., annual reports, protocol amendments) prior to submission to ensure overall quality, compliance and timelines.
• Lead strategic regulatory discussions and the drafting of documents for health authorities (e.g., meeting requests/scientific advice requests, and other complex regulatory submission documents).
• Identify, develop and implement regulatory strategies for the global assigned portfolio as well as standards in alignment with short and long term business plans.
• Lead regulatory activities with emphasis on regulatory strategy and the preparation, review and evaluation of documents for health authorities.
• Combine knowledge of scientific, regulatory, and business processes to properly drive the execution of Eisai's regulatory strategies.
• Consistently identify strategic regulatory opportunities and threats to ensure appropriate resources to mitigate risks and maximize success.
• Direct, and manage financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assess resource needs for respective program(s) within regulatory strategy.
• Identify and lead initiatives to continuously improve regulatory strategy related processes and systems with key stakeholders.
• Ensure deliverables are clearly defined within teams, important information cascaded well and accountability driven throughout the organization.
• Responsible for direct people management in terms of goal setting, performance management, development and engagement.

Qualifications:

• Bachelor's degree (Master's preferred) and 12+ years of relevant experience.
• Experience in Life Sciences industry preferred.
• Bachelor's or advanced degree in sciences or related field with significant experience in regulatory/R&D area with drug development and regulatory experience in pharma/biotech industry. OR a combination of equivalent education and experience.
• Proven experience in strategy development within area, operational management of regulatory strategy processes through cross-functional teams, as well as budget planning & management.
• Demonstrated experience/working knowledge in the design and process of clinical trials including clinical data collection and analysis and preparation of regulatory submissions, preferred.
• Demonstrated track record of interfacing effectively with FDA with some experience with health authorities; extensive experience with FDA laws, regulations and guidances, as well international regulation.
• Significant project management experience leading multiple critical complex regulatory strategy projects and programs; major submissions (NDA/BLA/MAA/J‑NDA) experience, preferred.
• Proven experience managing large regulatory strategy teams directly/indirectly in a leadership capacity, 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) #LI-MI Bachelor's degree (Master's preferred) and 12+ years of relevant experience. Experience in Life Sciences industry preferred.

Skills:

• Communication & Cross-functional Influence
• Critical Thinking & Business Agility
• Mentoring/ People Development
• Project Management
• Regulatory Strategy Acumen

Eisai Salary Transparency Language: The annual base salary range for the Senior Director, Global Regulatory Affairs, Neurology is from :$249,100-$327,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. 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.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.

Right To Work E-Verify Participation At Eisai Inc., human health care (hhc) is our goal. We give 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 Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.