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Executive Director Of Regulatory Affairs ( Neurology)

Woodcliff Lake, NJ 07677

Posted: 06/09/2025 Employment Type: Permanent Category: Life Sciences Job Number: 261643 Pay Rate: $270k to $350K

Job Description

Executive Director of Regulatory Affairs (Neurology) 
Location: Nutley, NJ (Hybrid Postion) On Site 2 Days a Week 
Salary range: $270k to $350K + Bonus

Lloyd Staffing is searching for an Executive Director of Regulatory Affairs
Our client is 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.

Job Summary
The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai’s products under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory/business objectives.

  • The Executive Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. This includes oversight, guidance, and management of GRS teams responsible for large, late stage development program or for multiple early stage development programs. Using a hands on approach, this position will ensure the completion of all goals and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This role requires experience with NDA/BLA, MAA and supplementary applications.

Essential Functions

  • Provide global regulatory leadership in support of the global development, registration, and life-cycle management of products under responsibility.
  • Ensure the efficient, timely and compliant execution of regulatory strategies and programs.
  • Directs and manages a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products.
  • May serve as the lead regulatory representative on the project team throughout the product lifecycle.
  • Provide senior staff advice and guidance on regulatory issues, especially for US.
  • Responsible for oversight and strategic planning of the meetings with FDA, EMA, PMDA. Provide strategic support for meetings with other Health Authorities, the CDE.
  • Actively participates in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and development of corrective actions.
  • Keep abreast of changes in the regulatory environment and implement necessary adaptations.
  • Provide expert opinion, advice and strategic direction on emerging policy & intelligence matters.
  • Ensure continued engagement, development and performance management of staff.
  • Determining timelines and budgets for program activities and report accordingly.
  • Lead and participate in global regulatory initiatives and committees.

Job Requirements

Qualifications

  1. Bachelor's degree and at least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.
  2. Education area of study in a scientific discipline with a Master’s or other advanced degree preferred.
  3. Position involves line management responsibility for personnel in US and UK and has both direct and indirect reports.   Demonstrated success in leading and managing teams is required.
  4. Experience in the successful prosecution of NDA/BLA, MAA and supplementary applications in essential.
  5. Demonstrated track record of interfacing effectively with FDA, EMA and other global regulatory agencies.
  6. Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).Publish
  7. Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
  8. Excellent operational skills including planning, organizing and ability to motivate and lead others.
  9. Excellent verbal and written communication skills and comfortable presenting to all levels of an organization including its Senior Management.
  10. Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure an acting with integrity and credibility to build trust.

  1. Ability to effectively work with a variety of personnel across a matrix organization and work collaboratively with cross functional teams.
  2. Sense of urgency and perseverance to achieve results.

  • Bachelor's degree (Master's preferred) and 10+ years of relevant experience.
  • Experience in Life Sciences industry preferred.

Meet Your Recruiter

Erin Hoke

My career began in the hospitality industry, but I sought a change for better work-life balance and family considerations.  I moved into the world of recruiting in 1999, I started in light industrial roles and gradually specialized in contract and permanent placements across a wide range of technical industries.

In 2006, I co-founded Recruiting Resources with my father, focusing on professional services and human resources staffing for both small and national companies. In 2011, I became an independent recruiter, partnering with a small Firm in the Maryland area where I concentrated on sourcing talent primarily for the Life Sciences industry but also expanded into non-technical areas.

Throughout my career, I have valued personal connections and helping individuals find positions that align with their expertise and lifestyle. My journey reflects adaptability, entrepreneurship, and a passion for facilitating meaningful career opportunities for others.  I joined Lloyd Staffing in Aug 2024 to specialize again in Life Sciences.

In my free time, I spend most of my time with my son. We have become quite the fishermen over the past 5 years. 

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About Woodcliff Lake, NJ

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