Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory Affairs based in the United States.

This is a strategic regulatory leadership opportunity within a clinical-stage biotechnology environment focused on transformative gene therapies. The role will shape global regulatory strategy for assigned development programs and provide critical guidance across preclinical and clinical development. You will work closely with multidisciplinary teams spanning Clinical, CMC, Quality, Medical, Nonclinical, and Project Management. The position offers significant exposure to U.S., European, and other global health authorities, including opportunities to lead agency interactions. You will help drive high-quality regulatory submissions, development strategies, designations, and health authority communications. Success will require strong scientific judgment, strategic thinking, and the ability to translate complex regulatory considerations into clear recommendations. This fully remote U.S.-based role is ideal for a seasoned regulatory professional motivated by advancing innovative therapies for patients with serious diseases.

Accountabilities:: Lead regulatory strategy: Serve as the Regulatory Affairs lead or representative for assigned development programs, providing strategic guidance and interpreting regulatory requirements to support clinical and preclinical development.

Develop global regulatory plans: Create and execute integrated regulatory strategies, timelines, and approaches that support global development objectives, including European regulatory strategies.

Drive regulatory submissions: Lead or support preparation and submission of CTAs, INDs, PINDs, amendments, scientific advice packages, regulatory designation requests, and other development-stage or marketing application materials as appropriate.

Ensure submission quality: Lead regulatory document reviews, comment resolution, and approval processes to ensure materials are scientifically sound, strategically aligned, complete, and submission-ready.

Manage health authority interactions: Prepare and contribute to meeting requests, briefing documents, responses to agency questions, and other communications with regulatory authorities, including U.S., European, and other global agencies.

Influence cross-functional decisions: Participate in governance forums and project teams, clearly communicating regulatory strategies, risks, options, recommendations, and development implications to stakeholders and senior leadership.

Partner across functions: Collaborate with Clinical, Nonclinical, CMC, Quality, Medical, Project Management, and other teams to integrate regulatory strategy into development plans and ensure timely execution.

Provide European regulatory leadership: Offer guidance on European regulatory requirements, procedures, expectations, agency engagement, and expedited development pathways where appropriate.

Oversee external partners: Manage or provide oversight of regulatory consultants, CROs, vendors, and other external partners supporting assigned activities.

Support strategic transactions: Contribute regulatory expertise to business development, licensing, and regulatory due diligence activities when needed.

Maintain regulatory compliance: Stay current with evolving regulations, guidance, directives, and health authority expectations while ensuring activities meet applicable quality standards and internal procedures.

Champion accountability and collaboration: Operate with sound judgment, strong ownership, and a patient-focused mindset while navigating a fast-paced, matrixed environment.

Requirements

Education: Bachelor's degree in a scientific, engineering, medical, pharmacy, or related discipline is required; an MS, PhD, PharmD, MD, or equivalent advanced degree is preferred.

Regulatory experience: 10+ years of regulatory affairs or related drug development experience within pharmaceutical, biotechnology, or a comparable industry environment.

Clinical development expertise: Demonstrated experience supporting or leading regulatory strategy, submissions, and health authority interactions for clinical-stage development programs.

Advanced therapeutics experience: Experience authoring and submitting PINDs, CTAs, INDs, or comparable regulatory materials for biologics, gene therapy, cell therapy, or other advanced therapeutic technologies.

Regulatory writing: Strong ability to author, review, and strategically contribute to briefing packages, designation requests, clinical trial applications, amendments, agency responses, and marketing application components.

Global regulatory knowledge: Strong understanding of FDA, EMA, MHRA, and other relevant health authority regulations, guidelines, procedures, and expectations.

European expertise: Experience with European regulatory strategy, including CTAs, scientific advice, PRIME, ILAP, MAA planning, or interactions with European regulatory bodies is highly valued.

Strategic leadership: Demonstrated ability to develop and execute integrated global regulatory strategies for clinical-stage and registration-directed programs.

Therapeutic expertise: Experience with AAV-based gene therapy, rare diseases, biologics, or advanced therapeutic medicinal products is preferred.

Communication and influence: Excellent written and verbal communication skills, with the ability to build clear regulatory rationales and explain complex issues to cross-functional teams and senior leaders.

Collaboration: Strong interpersonal, negotiation, influencing, and stakeholder-management skills, with the ability to operate effectively within a matrixed organization.

Judgment and execution: Strong problem-solving skills, attention to detail, accountability, and the ability to make sound decisions in a fast-paced environment.

Technical proficiency: Experience with Veeva RIM or similar regulatory information management systems, as well as Microsoft Office and other commonly used regulatory tools.

Mission orientation: A patient-focused mindset and genuine enthusiasm for contributing to the development of innovative therapies for people living with serious diseases.

Benefits

Fully remote position for candidates based in the United States.

Opportunity to influence global regulatory strategy for clinical-stage gene therapy programs.

Broad exposure to U.S., European, and other international health authorities.

Strategic and cross-functional leadership opportunities across drug development.

Competitive compensation and benefits package.

Opportunity to contribute to innovative therapies addressing serious and life-threatening diseases.

Collaborative, science-driven environment with a strong emphasis on innovation, accountability, and professional growth.

Inclusive workplace committed to equal opportunity and supporting employees with diverse backgrounds and perspectives.

Reasonable accommodations available for qualified individuals with disabilities and disabled veterans.

Work within an organization focused on advancing innovative science and delivering transformative medicines to patients in need.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1