Remote Regulatory Strategy Lead - Gene Therapy

AskBio Inc.; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

AskBio Inc. in the United States offers a secondment opportunity for a Director of Regulatory Affairs, serving as the U.S.-based regulatory strategy lead for assigned development programs.

You will drive global regulatory strategy, provide leadership for regulatory activities, and collaborate with cross-functional teams to ensure alignment with health authority expectations across FDA/EMA and other agencies.

Qualifications

• Bachelor’s degree in a scientific, engineering, medical, pharmacy, or related discipline.
• 10+ years of regulatory affairs or related drug development experience in pharma/biotech.
• Experience supporting and/or leading regulatory submissions and health authority interactions for clinical-stage programs.
• Experience with authoring and submitting PINDs, CTAs and INDs for biologics, gene therapy, cell therapy, or other advanced therapies.
• Strong understanding of FDA, EMA, MHRA, and other health authority regulations and guidelines.
• Excellent written and verbal communication, with ability to build regulatory rationales for stakeholders.
• Proficiency with VEEVA RIM or similar systems and MS Office.
• Mission-driven, patient-focused mindset in fast-paced environments.

Responsibilities

• Serve as Regulatory Affairs lead or representative for assigned programs, providing strategic regulatory guidance and interpretation to support product development.
• Develop and execute integrated regulatory strategies and timelines for global development, including European strategies.
• Lead or support preparation and submission of regulatory documents for clinical programs (CTAs, amendments, briefing packages, designations, and filings).
• Lead regulatory document review, comment resolution, and approval processes to ensure quality and alignment with strategy.
• Prepare and/or contribute to health authority meeting requests, briefing documents, and responses to questions.
• Participate in governance meetings and cross-functional project team discussions, communicating regulatory strategy and risks.
• Collaborate with Clinical, Nonclinical, CMC, Quality, Medical, and PM to integrate regulatory plans.
• Provide guidance on European requirements and expedited development mechanisms where appropriate.
• Manage external regulatory partners, CROs, and vendors supporting regulatory activities.
• Support regulatory due diligence for business development/licensing opportunities.

Skills

Regulatory strategy

Cross-functional leadership

FDA/EMA/MHRA regulations

Regulatory submissions

Health authority interactions

VEEVA RIM

Written/verbal communication

Education

Bachelor’s degree in science/engineering/medical/pharmacy

Advanced degree (MS/PhD/PharmD/MD) in related field

Tools

VEEVA RIM

Microsoft Office

Job description

AskBio Inc. in the United States offers a secondment opportunity for a Director of Regulatory Affairs, serving as the U.S.-based regulatory strategy lead for assigned development programs.

You will drive global regulatory strategy, provide leadership for regulatory activities, and collaborate with cross-functional teams to ensure alignment with health authority expectations across FDA/EMA and other agencies.