Director, Regulatory Affairs

EXPERIENCE & QUALIFICATIONS

• Graduate degree in a life science; such as Ph.D., M.D., or Pharm.D. highly preferred.
• At least five years of regulatory project lead experience required.
• Recent hands-on experience leading BLA submissions, preferably to FDA’s Center for Biologics Evaluation and Research (CBER).
• Recent experience supporting biologics development.
• Demonstrated experience with successful submission and FDA approval of a BLA or New Drug Application (NDA).
• Experience serving as the point of contact for FDA and other health authorities and leading formal health authority meetings.
• Knowledge of FDA content and technical requirements for BLA submissions.
• Demonstrated experience developing and implementing regulatory strategies for U.S. Investigational New Drug applications (INDs), BLAs, and/or NDAs.
• Ability to lead cross-functional teams, manage submission timelines, and deliver under tight deadlines and high-pressure conditions.
• Basic computer proficiency, including Microsoft Word, Excel, PowerPoint, and Outlook.
• Effective written and verbal communication in English, strong interpersonal skills, and demonstrated cross-functional leadership.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross-functional teams.
• Excellent organizational and time management skills with the ability to set priorities in a timely manner.
• High degree of flexibility and adaptability.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• Adhere to company and facility policies and procedures, including SOPs, training, and meeting requirements; maintain required training and certifications.
• Observe safety precautions and regulations and report safety hazards and potentially unsafe working conditions.
• Report to work on time and as scheduled, with availability to meet tight deadlines and peak-period demands.
• Represents the organization in a positive and highly professional manner.

• Serve as the FDA point of contact for assigned development programs and coordinate regulatory communications.
• Co-lead cross-functional Biologics License Application (BLA) submission efforts, coordinating contributions and timelines across functions.
• Serve as regulatory strategist and regulatory project lead or co-lead for assigned projects.
• Develop and implement U.S. and global regulatory strategies for assigned projects.
• Serve as subject matter expert for clinical modules in regulatory filings.
• Monitor and interpret new policies and guidance from FDA and other health authorities and assess their impact on assigned programs and company business.
• As assigned, serve as global regulatory lead, coordinating document preparation and interactions with other health authorities.
• Coach and mentor junior staff supporting the Regulatory Affairs team, as needed.