Join the World's Top Legal Talent Network

Reporting to: Vice President, Regulatory Affairs

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will …

• Align with your values and grit, and passion for innovative science.
• Leverage your deep knowledge of Regulatory Affairs to support our innovative science and allow you to have a major impact on our mission to support our patients.
• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.

Accountabilities And 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.
• In partnership with the Vice President, Regulatory Affairs, act as a 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.

Requirements: Proven Experience, Skills, and Education:

• Bachelor’s degree required, ideally in a science-related field; advanced degree, e.g., Ph.D., preferred.
• Minimum 10 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.

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.

Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.