Associate Director, Regulatory Strategy

Alpha-9 Oncology; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

20 vacation days

5 sick days

Technology allowance

Commuter reimbursement

Extended health benefits

Paid holidays

Job summary

Alpha-9 Oncology seeks an experienced Associate Director, Regulatory Affairs to lead global regulatory strategy and submission planning across our clinical pipeline. Reporting to the Vice President, Regulatory Affairs, this hands‑on role helps shape strategy and execute submissions while supporting health authority interactions across programs.

The ideal candidate brings strong global regulatory knowledge, sound judgment, and a collaborative approach.

Qualifications

• Advanced degree in a scientific, pharmacy, or related discipline and 8+ years of regulatory affairs experience.
• Experience supporting global drug development programs with INDs, CTAs, and other submissions.
• Strong knowledge of FDA, ICH, EU regulations and health authority interactions.

Responsibilities

• Plan and manage regulatory activities across clinical development programs including CMC, nonclinical and clinical.
• Develop and implement regulatory strategies to enable timely approvals globally.
• Lead preparation, review, and submission of regulatory materials (INDs, amendments, CTAs, annual reports, safety reports).
• Coordinate health authority interactions and maintain submission plans and timelines.
• Ensure regulatory records are compliant and inspection-ready.

Skills

Regulatory strategy

Global submissions

Cross-functional leadership

Regulatory intelligence

Project management

Communication

Independent ownership

Education

Advanced degree in a scientific field

Tools

eCTD submissions

Job description

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.

How You’ll Contribute

Regulatory Strategy & Program Support

• With minimal supervision, 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.

Regulatory Submissions & Health Authority Interactions

• 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.

Regulatory Operations & Compliance

• 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.

The Skills You Bring

• 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.

What’s In It For You:

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical‑stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.