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.

• Lead or assist in the preparation and submission of regulatory documents, including CTAs, amendments, scientific advice briefing packages, regulatory designations, and marketing application initiatives.

• Oversee the review of regulatory documents, resolution of comments, and approval workflows.

• Prepare or assist in the creation of health authority meeting requests, briefing materials, responses, and other regulatory communications.

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

• Convey regulatory strategies, risks, options, and recommendations to stakeholders and senior management.

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

• Provide advice on European regulations, procedures, agency interactions, and expedited development pathways.

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

• Assist in regulatory due diligence for business development or licensing prospects.

• Ensure all regulatory activities adhere to applicable 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 similar sectors.

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

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

• Competence in writing, reviewing, and providing strategic insights on regulatory documents.

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

• Exceptional written and verbal communication abilities.

• Strong interpersonal, collaborative, negotiation, and influencing skills.

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

• Proficiency in Veeva RIM or similar systems and Microsoft Office.

• A mission-driven, patient-centered approach.

• An advanced degree in a scientific, medical, pharmacy, or related field is preferred.

• Experience with European regulatory strategy is preferred.

• Familiarity with integrated global regulatory strategies is preferred.

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

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.

• Flexible work arrangements to promote work-life balance.