Director – Regulatory Affairs

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

📋 Description

• Oversee the regulatory strategy and execution for YUVEZZI™, encompassing all NDA support and ongoing regulatory filings.

• Manage the submission of regulatory documents, including NDAs, DMFs, PAIs, and annual commitments for YUVEZZI™.

• Formulate and implement regulatory strategies to facilitate product development, approvals, and lifecycle management.

• Prepare and review various regulatory documents (INDs, NDAs, DMFs, annual reports, amendments, and responses to agency inquiries).

• Lead communications with the FDA and international health authorities, including regulatory meetings, negotiations, and responses to inquiries.

• Ensure adherence to regulatory requirements set by the FDA, ICH, EMA, and other global standards.

• Collaborate cross-functionally with clinical, CMC, non-clinical, and commercial teams to ensure regulatory strategies align with business goals.

• Monitor changing regulatory requirements and provide internal teams with insights on potential impacts to development programs.

• Represent Regulatory Affairs in strategic discussions, influencing significant decisions related to clinical development, commercialization, and regulatory activities with licensing partners.

• Participate as a member of the PRC committee to evaluate commercial advertising and similar documents.

⛳️ Requirements

• A Bachelor’s degree or an equivalent amount of industry experience is required; an advanced degree (MS, PhD, PharmD) is preferred.

• At least 10 years of regulatory affairs experience in the pharmaceutical or biotechnology sector; experience in ophthalmology is strongly preferred.

• Demonstrated experience with NDAs in the US (DMF and pharmacovigilance experience is advantageous).

• Strong expertise in small molecules; experience with biologics is a plus but not mandatory.

• Comprehensive understanding of US regulatory requirements; familiarity with global regulatory frameworks (EMA, PMDA, etc.) is also preferred.

• Experience leading regulatory engagements with the FDA and other global health authorities, particularly in Canada, LatAm, AsiaPac, and MENA regions.

• Proven ability to develop and implement regulatory strategies from initial development through to commercialization.

• In-depth knowledge of CMC regulatory requirements for small molecules and biologics.

• Exceptional project management skills, with the ability to prioritize tasks effectively in a fast-paced environment.

• Experience participating in a PRC committee process.

• Familiarity with a regulatory information management system; experience with Veeva RIM would be an asset.

• Proficiency in MS Office applications, particularly Excel, Word, and PowerPoint.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance plans.

• Flexible spending accounts for health and dependent care.

• Short-term, long-term, and life/AD&D insurance coverage.

• Employee Assistance Program.

• 20 paid vacation days, 12 paid holidays, and 12 sick days.

• 401(k) Retirement Plan with a 100% company match up to 4% and immediate vesting.

• Options for hybrid work arrangements.

• Access to wellness resources.

• Stock options available.