Avalo Therapeutics

Director of Regulatory Affairs

Chesterbrook, PA · Director

Sponsorship not specified$10k-$15kDetected 29 days ago

Product ManagementHRFDA RegulatoryLeadershipRegulatory Affairs

About the role

The Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities.
The ideal candidate will bring a balanced mix of strategic and operational regulatory expertise.
Serve as the Regulatory Affairs representative on cross-functional project teams and provide proactive, strategic guidance to advance program objectives.

Design, lead, and implement global regulatory strategies to support the development, registration, and lifecycle management of assigned programs.
Identify regulatory risks, develop mitigation plans, and communicate recommendations to project teams and senior leadership.
Lead the planning, preparation, review, and submission of regulatory documents throughout the product lifecycle.
Lead and coordinate routine regulatory submissions independently while supporting more complex registration activities under the guidance of senior regulatory leadership.
Support preparation and maintenance of future NDA/BLA and ex-U.S. marketing application activities.
Serve as a key point of contact with FDA and support interactions with ex-U.S. regulatory agencies.
Lead preparation of regulatory briefing materials, meeting requests, information packages, and responses to agency inquiries.
Participate in and support regulatory authority meetings, teleconferences, and written communications.

All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.
All resumes must be submitted through the appropriate process.

Bachelor's degree in scientific discipline required.
Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
10-15 years of Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry.
Minimum of 5 years of experience within a small or emerging biotechnology company preferred.
Demonstrated experience supporting late-stage clinical development programs.
Experience supporting biologics development programs preferred.
Experience interacting directly with FDA and supporting ex-U.S. regulatory activities.
Experience managing CROs and external consultants supporting global regulatory submissions and agency responses.

Deep understanding of global drug development and regulatory requirements for biologics.
Strong knowledge of FDA regulations and familiarity with EMA and other international regulatory frameworks.
Ability to thrive in a fast-paced biotechnology environment while managing multiple priorities and deadlines.
Experience working in a cross-functional team
Working in a fast-paced environment to ensure timelines are consistently met
Less than 5% travel.

Proven experience authoring, reviewing, and managing a broad range of regulatory submissions, including INDs, CTAs, amendments, IND Safety Reports, DSURs, annual reports, and briefing packages.

Collaborate with senior regulatory leadership on major strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA planning, and labeling activities.
Manage external regulatory consultants and CRO partners supporting global CTA submissions, maintenance activities, and health authority responses.

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases.

This listing is sourced directly from Avalo Therapeutics's careers page and normalized into a canonical job model.