Senior Director, Regulatory Strategy Consulting

Overview

Career Opportunities with Halloran Consulting Group

Senior Director, Regulatory Strategy Consulting

Department : Consulting

Location : Boston, MA

Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Regulatory team as a Senior Director, Regulatory Strategy Consulting today!

Reporting to the Vice President of Regulatory Affairs, this leader will shape and drive global regulatory strategies across diverse therapeutic portfolios.

In this role, you will combine deep regulatory expertise, strategic foresight, and business development acumen to deliver innovative solutions for our clients. You will lead cross-functional teams, represent clients in critical health authority engagements, and act as a trusted partner to senior leadership.

The ideal candidate thrives at the intersection of strategy and execution, balancing technical mastery with consultative leadership to deliver meaningful impact for clients and the organization.

Characteristic Duties

Regulatory Strategic Leadership

• Provide regulatory strategy and leadership to our clients through design and implementation of global regulatory strategies across development programs, proactively identify and mitigate regulatory risks to ensure alignment with client business objectives.
• Lead the planning of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses, represent the client in meetings with FDA and global health authorities, lead rehearsals, and moderate live health authority meetings and partner with internal teams and external client teams / vendors to ensure quality, timely, and compliant regulatory submissions and deliverables.
• Drive delivery team accountability for regulatory milestones and timelines; escalate and resolve critical path issues.
• Meet a target billable utilization of 50% while driving client satisfaction and delivery excellence.

Team Leadership and Talent Development

Business Development and Account Growth

Operational Excellence and Process Improvement

Thought Leadership and Industry Impact

Qualifications

Required :

Preferred :

Compensation

The targeted base compensation range for this position is between $200,000.00 and $260,000.00 annually. Please note : this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.

Halloran Benefits and Perks

The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day-to-day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. In addition to this, Halloran offers a flexible PTO Policy and opportunities for continued learning.

Notice

Halloran does not sponsor visas for employees.

All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.

EEO Notice

Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by an authorized representative of Halloran.

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