Senior Director, Global Regulatory Affairs, Neurology

Eisai•Nutley, NJ

11d•Hybrid

About The Position

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.

Requirements

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.
Must be available for regular business travel (conferences, congresses, team meetings, audits and inspections)
Communication & Cross-functional Influence
Critical Thinking & Business Agility
Mentoring/ People Development
Project Management
Regulatory Strategy Acumen

Nice To Haves

Experience in Life Sciences industry preferred.
Demonstrated experience/working knowledge in the design and process of clinical trials including clinical data collection and analysis and preparation of regulatory submissions, preferred.
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.

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.