Director, Regulatory Affairs

Own the global regulatory strategy that carries breakthrough cell therapies from early development through health-authority approval and into the hands of patients.

Our client is a global biotechnology company advancing the next generation of cell therapy, with a portfolio that spans autologous, allogeneic, and in vivo approaches across CAR-T, TCR-T, and NK-cell platforms. With an approved commercial cell therapy already reaching patients and a fast-growing early-stage pipeline, the organization is expanding its Regulatory Affairs team to support programs across the full development lifecycle.

The Director, Regulatory Affairs independently develops, coordinates, and executes global regulatory strategies across a portfolio that spans a commercial-stage asset and early-stage programs approaching their first regulatory filings. This is a strategy-forward leadership role rather than a submission-desk seat. You will represent Regulatory Affairs on global cross-functional teams, interface directly with the FDA and other health authorities to align on development strategy, and guide programs from early development through registration and post-marketing. The position carries meaningful weight in early development and regulatory strategy, so success depends as much on the judgment to formulate innovative, forward-looking strategies as on the discipline to execute high-quality submissions on time. You will also partner closely with a key collaboration partner on a commercial-stage asset.

Essential Duties and Responsibilities

This list represents the major duties of the role and is not all-inclusive. The successful candidate may be asked to perform related duties beyond those described here.

Global Regulatory Strategy & Leadership

• Independently develop innovative, robust global regulatory strategies and ensure their efficient and effective execution across pipeline programs.
• Serve as the regulatory representative on global cross-functional development teams, partnering with other functions to ensure efficient execution of regulatory strategy.
• Provide oversight on regulatory strategy implementation across assets spanning early development through post-marketing.
• Coach and mentor junior regulatory team members in their roles on global project teams.
• Maintain a strong understanding of the competitive regulatory landscape in oncology, immunology, and cell therapy.

Health Authority Engagement

• Interface directly with the FDA and other health authorities to seek feedback and reach alignment on preclinical and clinical development strategies.
• Formulate innovative regulatory approaches designed to accelerate clinical development.

Submissions & Lifecycle Management

• Lead the team effort to prepare and submit INDs, CTAs, and BLAs, along with related supplements, amendments, and variations, ensuring timely, high-quality submissions.
• Oversee the maintenance of INDs, CTAs, BLAs, and ex-U.S. filings as required.
• Evaluate the need to develop in-vitro diagnostic or companion diagnostic tests for pipeline programs, and lead that effort as needed.
• Provide regular and timely updates to management on the status of all pending applications and planned submissions.

Cross-Functional & External Collaboration

• Partner closely with a key collaboration partner on a commercial-stage asset.
• Serve as the regulatory affairs reviewer on the promotional material review committee.
• Represent regulatory affairs in external collaborations and in internal cross-functional initiatives such as SOP development and business-process improvement.

Qualifications

The requirements below are representative of the knowledge, skills, and abilities needed to perform this role successfully.

Required

• A minimum of 7 years of regulatory affairs experience in drug development, with direct ownership of the filing and approval process across IND, CTA, BLA, and MAA submissions.
• Direct IND filing experience.
• A strong biologics regulatory background.
• Regulatory affairs experience in oncology and/or immunology.
• A strong command of global regulatory requirements across the drug development lifecycle, from early development through registration and post-marketing.
• Demonstrated ability to independently formulate and lead the execution of global regulatory strategies.
• Experience preparing major regulatory submissions, amendments, and supplements in both the U.S. and ex-U.S.
• Excellent written and verbal communication skills, strong organizational and prioritization skills, and the interpersonal skills to work effectively across medical, clinical, and manufacturing functions.

Preferred

• A PharmD or PhD (or equivalent) in a science or health-care field.
• Experience with biologics and cell and gene therapies.
• Experience across multiple therapeutic modalities.
• Experience with EU and/or Asia regulatory filings.
• Experience supporting or reviewing promotional materials, or a willingness to develop expertise in this area.
• Familiarity with companion diagnostic (CDx) development.
• Experience working within a complex partnership or collaboration environment.

Nice to Have

• Drug development experience in multiple myeloma.

Engagement and Location

• Structure: Full-time, permanent, direct-hire position.
• Location: Hybrid schedule based in Central New Jersey.

Base Salary: $190,000 to $250,000, plus a performance-based bonus and equity eligibility. The compensation offered will be commensurate with experience, skills, qualifications, and other relevant factors.

About the Search

This search is being managed by Summit Strategic Search on behalf of our client. This is a full-time, permanent position where the successful candidate will be hired directly by the end client.

Equal Opportunity Commitment: Summit Strategic Search and our client are equal opportunity partners. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, or disability status.

Accommodations and Support: We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at admin@summitstrategicsearch.com. We maintain a zero-tolerance policy for harassment and provide all employees with dedicated reporting channels to ensure a safe, professional work environment.

Selection and Onboarding: As this is a direct-hire role within a regulated industry, the end client's standard hiring protocols apply. This includes, but is not limited to, a comprehensive background check and drug screening prior to the start of employment. All hiring decisions are made solely by the end client.