Senior Director, Regulatory Affairs

Regulatory Affairs Leader

ImmunEdge is seeking an experienced Regulatory Affairs leader to develop and execute global regulatory strategies supporting the advancement of its portfolio of innovative therapeutics. This individual will serve as a strategic regulatory partner to Clinical Development, Clinical Operations, Research, Translational Medicine, CMC, Nonclinical, Quality, Pharmacovigilance, and executive leadership.

The successful candidate will combine sophisticated regulatory judgment with a pragmatic, hands-on approach and will translate evolving regulatory requirements into clear and executable development strategies.

Key Responsibilities:

• Develop and execute global regulatory strategies for assigned development programs from early development through registration and lifecycle management.
• Ensure regulatory strategy is integrated with clinical, nonclinical, CMC, translational, safety, and corporate development plans.
• Identify regulatory opportunities, risks, dependencies, and potential development pathways and provide clear recommendations to program and executive leadership.
• Interpret evolving regulatory requirements, precedents, and agency expectations and translate them into practical development recommendations.
• Evaluate opportunities for expedited development and review pathways where appropriate.
• Lead the strategy, preparation, and execution of interactions with the FDA and other global health authorities.
• Serve as a primary regulatory representative during health authority meetings and ensure alignment across cross functional teams regarding objectives, strategy, messaging, and follow up actions.
• Lead preparation of briefing documents, meeting requests, responses to regulatory questions, and other agency communications.
• Communicate regulatory feedback clearly to program teams and executive leadership and ensure resulting actions are incorporated into development plans.
• Lead regulatory planning and execution for INDs, CTAs, amendments, annual reports, safety related submissions, briefing packages, and other development stage submissions.
• Provide strategic oversight of future BLA, NDA, MAA, or other marketing application activities as programs mature.
• Establish submission strategies, timelines, responsibilities, and governance to support high quality and timely regulatory filings.
• Review and provide strategic direction on regulatory documents to ensure scientific consistency, appropriate positioning, and compliance with applicable requirements.
• Partner closely with Clinical Development, CMC, Nonclinical, Quality, Pharmacovigilance, and other functions to ensure readiness of submission content.
• Serve as the Regulatory representative on cross functional program teams and development governance forums.
• Provide regulatory leadership in the development of protocols, Investigator Brochures, clinical development plans, CMC plans, nonclinical strategies, and other core program documents.
• Advise program teams on the regulatory implications of development choices, including study design, endpoints, patient populations, manufacturing changes, and development sequencing.
• Develop and maintain regulatory risk assessments and mitigation plans for critical programs.
• Provide regulatory input into business development, diligence, partnership, and licensing activities as appropriate.
• Maintain strong awareness of evolving FDA, EMA, ICH, and other relevant global regulatory requirements and precedents.
• Monitor regulatory developments and competitor precedents relevant to ImmunEdge programs and therapeutic areas.
• Establish scalable regulatory processes, standards, and governance appropriate to the company's stage of development.
• Select and manage external regulatory consultants, vendors, and submission partners where appropriate.
• Ensure regulatory documentation, commitments, correspondence, and submission records are appropriately maintained.
• Build trusted partnerships across the organization and establish Regulatory Affairs as a proactive contributor to development strategy.
• Present regulatory strategies, options, risks, and recommendations to executive leadership in a clear and balanced manner.
• Build, manage, and develop internal Regulatory Affairs capabilities as the portfolio and organization grow.
• Manage departmental resources, external support, and budgets as appropriate to the scope of the position.

Qualifications:

• Bachelor's degree in a relevant scientific or health related discipline required. Advanced scientific, medical, or regulatory degree preferred.
• Significant progressive experience in Regulatory Affairs within biotechnology or pharmaceutical drug development.
• Demonstrated experience developing and implementing regulatory strategies for clinical stage therapeutic programs.
• Direct experience leading interactions with the FDA required. Experience with EMA and other global health authorities strongly preferred.
• Strong working knowledge of IND and CTA requirements and clinical development regulations. Experience with BLA, NDA, MAA, or other major marketing applications is strongly preferred for the Vice President level.
• Oncology, immuno-oncology, immunology, or other relevant therapeutic development experience strongly preferred.
• Experience working with biologics, multi-specific antibodies or other novel therapeutic modalities preferred.
• Strong understanding of the integration between clinical, nonclinical, CMC, quality, safety, and regulatory strategy.
• Demonstrated ability to identify complex regulatory issues, evaluate alternatives, articulate risk, and provide practical recommendations.
• Excellent written and verbal communication skills with the ability to influence senior technical and executive stakeholders.
• Experience operating effectively within a lean biotechnology environment and managing external regulatory resources.

Leadership Profile:

The successful candidate will be a strategic regulatory leader who is also comfortable operating at the level of detail required in a growing biotechnology company. This individual should be able to anticipate regulatory issues rather than simply respond to them, bring forward well considered options and recommendations, and help teams make thoughtful development decisions under uncertainty. The role requires excellent judgment, scientific credibility, accountability, collaboration, and the ability to move fluidly between long term regulatory strategy and near-term execution.

ImmunEdge offers a competitive employment package that includes an annual bonus plan, equity, and a generous benefits package including comprehensive health (medical, dental, and vision) insurance for our employees and their families, a 401k plan, FSA plans (medical, dependent), an Employee Assistance Plan, and a holiday and paid time off plan.

At ImmunEdge, we believe that a diverse, open, and inclusive environment and culture is key to our success. We will not be influenced in recruiting, hiring, promoting or any other employment practices by race, color, citizenship status, national origin, ancestry, sex, sexual orientation, gender identity/expression, age, religion, physical or mental disability, medical or genetic condition, marital status, veteran status, or any other characteristics protected under applicable federal, state and local laws. ImmunEdge will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable laws.