Senior Director, Regulatory Affairs

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

📋 Description

• Act as the main author and facilitate regulatory initiatives.

• Prepare, review, and submit various regulatory documents, such as INDs, CTAs, BLAs, and MAAs.

• Gather and organize regulatory materials while addressing inquiries from health authorities.

• Collaborate with Clinical, Pharmacovigilance, Biometrics, and CMC teams regarding regulatory submissions.

• Stay updated on global regulatory standards and contribute to efforts in regulatory intelligence.

• Assist in interactions with international health authorities by preparing materials for meetings and responses.

• Create regulatory documents, including CTD dossiers, IBs, clinical protocols, and both nonclinical and clinical study reports.

• Monitor regulatory commitments and timelines to ensure timely submissions and approvals.

• Evaluate emerging clinical data and operational activities for compliance with regulatory standards.

⛳️ Requirements

• A Bachelor’s degree is required; an advanced degree is preferred.

• Over 10 years of experience in a dynamic, high-volume document production setting.

• Minimum of 5 years of experience within the cell and gene therapy sector.

• Extensive knowledge of regulations and guidelines across various global jurisdictions, including the U.S., EU, and other significant regulatory bodies.

• Practical experience in preparing and submitting regulatory filings, such as INDs, CTAs, BLAs, and MAAs.

• Strong organizational abilities and meticulous attention to detail.

• Capability to effectively manage multiple priorities.

• Exceptional written and verbal communication skills, alongside strong collaboration abilities.

• Ability to excel in a fast-paced environment and adapt to evolving regulatory requirements.

• Experience with cell and gene-modified cell therapy.

• Expertise in global regulatory requirements.

• Preference for candidates with late-stage development experience.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD) benefits.

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

• Company-paid holidays, including a week off during the year-end holiday season.

• Bonus.ly recognition program, where points can be exchanged for desired items.

• A beautiful facility.

• An entrepreneurial, highly collaborative, and innovative work environment.