Associate Director, Global Regulatory Affairs

Eisai US; Nutley (NJ); Hybrid; USD 165,000 - 217,000; Full time

Job summary

Eisai US in Nutley, NJ seeks an Associate Director, Global Regulatory Affairs to provide comprehensive regulatory support for supplemental indications and lead early phase regulatory work for neurology or oncology candidates.

Responsibilities include leading submissions, strategizing global development approvals, and coordinating with cross-functional teams to optimize timelines and compliance.

Qualifications

• Bachelor's or advanced degree in sciences or related field.
• 6+ years of experience in regulatory/R&D 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.

Responsibilities

• Lead drafting and compilation of submissions to health authorities.
• Lead generation of reports, tracking submissions/approvals and documentation.
• Serve as Regional or Global Regulatory Lead; develop regulatory strategies for global approval of new medicinal products.
• Act as contact interfacing with regulatory authorities for assigned product(s).
• Develop regulatory strategy for assigned markets and support registration/post-licensing activities.
• Lead planning and assessment of product life cycle management activities.
• Partner with project teams to align regulatory resources and support needs.
• Develop contingency plans for regulatory objectives and risk mitigation.

Skills

Communication & Cross-functional Influ

Critical Thinking & Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's or advanced degree in sciences or related field

Equivalent education and experience

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 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.

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.

Qualifications

• 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.

Skills

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

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)

The annual base salary range for the Associate Director, Global Regulatory Affairs is from :$165,000-$216,500 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.

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.

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.