Associate Director, Global Regulatory Affairs

Eisai US

2d•$165,000 - $216,500

About The Position

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 Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for supplemental indications associated with an approved Neurology or Oncology agent. In addition, this position will serve as the lead support for early phase Neurology or Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.

Requirements

Bachelor's or advanced degree in sciences or related field.
6+ years of experience in regulatory/R&D area with strong experience in new drug regulated product strategy/submissions in pharma/biotech industry.
OR a combination of equivalent education and experience.
Experience mentoring and training team members on submission/regulatory strategy activities.
Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives.
Proven experience leading multiple/ large/complex project(s), tracking and managing regulatory strategy budgets, resources and regulatory filings.
Experience engaging with critical cross-functional stakeholders to drive processes/systems and outcomes.
Proven performance in earlier role.

Nice To Haves

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

Responsibilities

Lead the drafting, compilation of routine (and support complex) submissions of documents (e.g., meeting requests, iPSPs/PIPs, protocol amendments) to health authorities.
Lead the generation of reports, tracking of submissions/approvals and maintenance of documentation.
Serve as a Regional or Global Regulatory Lead; contribute to the development and implementation of regulatory strategies to facilitate optimum global approval of new medicinal products.
Act as a point of contact by interfacing and leading meeting with regulatory authorities for assigned product(s).
Develop and implement regulatory strategy for assigned markets and provide regulatory support for the registration/post-licensing activities of medicinal products.
Lead the planning, execution and assessment of product life cycle management activities and strategies.
Partner with project teams to assess regulatory support needs and align resources (e.g., sub teams) to provide regulatory support and guidance.
Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies.