Associate Director, Regulatory Strategy

Alpha-9 Oncology•Boston, MA

About The Position

Alpha-9 Oncology is seeking an experienced and energetic Associate Director, Regulatory Affairs to join our Regulatory Affairs team and play an important role in the development of our growing clinical pipeline. Reporting to the Vice President, Regulatory Affairs, this individual will help shape and execute global regulatory strategy, lead submission planning and execution, and support interactions with health authorities across our programs. This is a hands-on role with the opportunity to work closely with leadership and cross-functional teams while helping build the processes and capabilities that will support the continued growth of the Regulatory Affairs function. The ideal candidate brings strong global regulatory knowledge, sound judgment, and a collaborative, solutions-oriented approach. This is an opportunity to work on novel oncology programs, take meaningful ownership, and have a direct impact on regulatory strategy and program development in a fast-moving, nimble biotech environment.

Requirements

Advanced degree in a scientific, pharmacy, or related discipline, with 8+ years of relevant regulatory affairs experience in the biopharmaceutical industry.
Strong experience supporting global drug development programs, with hands-on experience across INDs, amendments, CTAs, and other clinical-stage regulatory submissions.
Experience developing and executing regulatory strategies and working directly with health authorities, preferably across the US and international markets.
Strong understanding of FDA, ICH, EU, and other global regulatory requirements and their application to clinical development programs.
Experience working cross-functionally with Clinical, CMC, Nonclinical, and other teams to develop high-quality regulatory submissions and advance program objectives.
Strong written and verbal communication skills, with the ability to clearly communicate regulatory considerations and recommendations to both technical and non-technical stakeholders.
Excellent organizational skills and attention to detail, with the ability to manage multiple priorities, timelines, and deliverables in a fast-paced environment.
A collaborative, solutions-oriented approach and the ability to work independently, take ownership, and jump in where needed.

Responsibilities

Plan and manage regulatory activities across clinical development programs, including clinical, nonclinical, and CMC activities.
Develop and implement regulatory strategies that support efficient development and timely approvals across global programs.
Represent Regulatory Affairs on cross-functional project teams, providing regulatory guidance and supporting program strategy and decision-making.
Partner closely with Clinical, CMC, Nonclinical, and other functions to incorporate regulatory considerations into program planning and execution.
Maintain current knowledge of FDA, EU, ICH, and other global regulatory requirements and incorporate relevant regulatory intelligence into program strategy.
Develop, communicate, and manage submission plans, timelines, and deliverables, proactively identifying and escalating risks to quality or timelines.
Lead the preparation, review, and submission of regulatory materials, including INDs, amendments, CTAs, annual reports, safety reports, meeting requests, briefing packages, and other US and international submissions.
Prepare and review regulatory documents, including IND content, briefing materials, health authority responses, designation requests, and other regulatory correspondence.
Support and manage health authority interactions, including meeting requests, briefing documents, agency responses, and related regulatory communications.
Review clinical, nonclinical, CMC, Investigator’s Brochure, labeling, and other supporting materials for accuracy, completeness, consistency, and regulatory acceptability.
Coordinate with clinical CROs and external publishing partners to ensure timely, accurate, and high-quality regulatory submissions.
Ensure regulatory submissions and records are maintained in a compliant, organized, and inspection-ready state.
Build scalable processes and systems that improve quality, streamline regulatory activities, and support the continued growth of the Regulatory Affairs function.
Continuously evaluate workflows, identify gaps, and implement practical improvements to strengthen regulatory operations.