Senior Director, Regulatory Affairs (Temp to Perm)

Senior Director, Regulatory Affairs (Temp to Perm)

Reporting to: Vice President, Regulatory Affairs

Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work by The Boston Globe, X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community.

With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.

We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals.

At X4 you will find...

• A team that values grit and passion of innovative science.
• The opportunity to leverage your knowledge of Regulatory Affairs to support our innovative science and allow you to have a major impact on our mission to support our patients.
• A collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.

Your Responsibilities:

• Lead and implement global regulatory strategies to meet the corporate objectives for the assigned asset(s).
• Provide Regulatory Affairs representation on cross-functional project teams; be a proactive, strategic partner contributing to advancing the regulatory and scientific objectives of the assets in scope.
• Monitor changes in regulatory requirements and medical innovation in the relevant therapeutic areas; insightfully assess their potential impact to educate and inform project team(s) and leadership decisions.
• Identify potential regulatory risks associated with the strategic and operational regulatory plans; propose options to mitigate and communicate these in a timely, efficient manner.
• Act as point of contact with the FDA, interact directly or indirectly with ex-US Health Authorities, and manage consultant teams assisting the regulatory efforts.
• Lead and participate in the planning, preparation and delivery of information packages supporting regulatory submissions throughout the asset's life cycle, including but not limited to briefing documents, INDs and CTAs and associated amendments, NDA/BLA, MAA, regulatory obligations (e.g., orphan drug annual report), etc.
• Represent the Company at meetings with Regulatory Authorities.
• Participate in functional and cross-functional initiatives and taskforces.
• Provide regulatory assessment to assist business development during due diligence activities, as needed.

What You Will Bring:

• Bachelor's degree required, ideally in a science-related field; advanced degree, e.g., Ph.D., preferred.
• A minimum of 12 years in the biotechnology and/or biopharmaceutical industry.
• Minimum 8 years in a Regulatory capacity with experience in several therapeutic areas, preferably through commercialization. Experience in Rare Disease is highly valuable.
• Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas and prior experience with small molecules and/or biologics.
• Deep knowledge of guidelines and regulations required to develop the overall regulatory strategy. Strong ability to interpret new regulatory guidance.
• Demonstrated experience interacting with the US FDA, EU, EMA, and other regulatory agencies.
• Proven experience in the review, authoring, and/or managing of components of regulatory submissions such as of INDs, CTAs, NDAs/BLAs or MAAs, and their maintenance.
• Known reputation for integrity and professionalism.
• Expertise in all phases of drug development, including Regulatory experience implementing the life cycle of a product from Phase III to commercialization in several therapeutic areas.
• Excellent oral and written communication skills.
• Proven ability to lead, proactively retain and develop staff
• Demonstrated experience adapting to different management styles to achieve success
• Able to be forward looking by assessment and understanding of strategic opportunities and communicate to management

This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

About Us

Pipeline

X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.

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