Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Regulatory Affairs lead or representative for designated programs, offering strategic regulatory advice and interpretation.

• Create and implement comprehensive regulatory strategies and timelines that align with global development and European regulatory goals.

• Oversee or assist in the preparation and submission of regulatory documents, which include CTAs, amendments, scientific advice briefing packages, regulatory designations, and marketing application activities.

• Direct the review, comment resolution, and approval processes for regulatory documents.

• Prepare or assist with health authority meeting requests, briefing documents, responses, and regulatory communications.

• Lead or engage in governance meetings, cross-functional project discussions, and interactions with regulatory agencies.

• Collaborate with Clinical, Nonclinical, CMC, Quality, Medical, Project Management, and other departments.

• Provide expertise on European regulatory requirements, procedures, opportunities, and expedited development mechanisms.

• Manage or supervise external regulatory partners, consultants, CROs, and vendors.

• Assist with regulatory due diligence for business development or licensing opportunities.

• Ensure that regulatory activities adhere to relevant regulations, guidelines, internal procedures, and quality standards.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, medical, pharmacy, or related field.

• Over 10 years of experience in regulatory affairs or related drug development within the pharmaceutical, biotechnology, or associated industries.

• Proven experience in supporting or leading regulatory submissions, health authority interactions, or regulatory strategy for clinical-stage development programs.

• Experience in authoring and submitting PINDs, CTAs, and INDs for biologics, gene therapy, cell therapy, or other advanced therapeutic technologies.

• Ability to write, review, and provide strategic insights on regulatory documents.

• Strong understanding of FDA, EMA, MHRA, and other health authority regulations, guidelines, procedures, and expectations.

• Exceptional written and verbal communication skills.

• Strong interpersonal, collaboration, negotiation, and influencing abilities in a matrixed, fast-paced environment.

• Sound judgment, problem-solving skills, attention to detail, and accountability.

• Proficiency in VEEVA RIM or similar systems and Microsoft Office applications.

• A mission-driven, patient-focused mindset.

• Preferred: advanced degree and experience with European regulatory strategy, integrated global regulatory strategies, AAV-based gene therapy, rare diseases, biologics, or advanced therapeutic medicinal products.

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Collaborative and innovative work environment.

• Competitive salary and performance-based bonuses.