Description
Position Overview
• Work Location: New York City, NY Or Remote.
• Reports To the Senior Director, Regulatory Affairs
The Manager, Regulatory Affairs is responsible for executing company regulatory strategies in compliance with established regulations and guidelines, including the on-time filing of high-quality regulatory submissions. This individual will be a team player with a roll-up-the sleeves, can-do attitude and will work closely with and reports to the Senior Director, Regulatory Affairs. This role will be an integral part of the transformative shift the company is making as we move into late-stage clinical development.
Requirements
Accountabilities and Responsibilities
• Participate in the development and implementation of regulatory strategies for therapeutic programs from candidate selection through post-marketing support
• Provide regulatory representation and guidance to cross-functional project teams as needed. Collaboratively develop regulatory strategies to support nonclinical and clinical activities across various development programs and provide guidance on regulatory submission requirements
• Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials
• Coordinate the authoring, editing, review, preparation, submission and archival of regulatory documents (including routine correspondence, INDs/CTAs, BLAs/MAAs, Annual Reports, Meeting Packages, Amendments, Supplements, Orphan Drug Applications, etc.) with minimal oversight
• Develop and manage project timelines for regulatory submissions
• Ensure submissions are complete, well-written, and meet all relevant regulatory requirements for supervisory review and approval
• Develop positive relationships with internal functional groups and contract research organizations
• Manage interactions with regulatory authorities as directed, to advance product development programs and maintain them in good standing
• Monitor the evolving cell and gene therapy regulatory landscape, including new guidance and competitive approval precedents, and communicate recommendations to management and program teams
• Support gene therapy-specific requirements including long-term follow-up commitments, and pharmacovigilance reporting
• Maintain current knowledge of FDA and international regulations, guidance and standards applicable to company products
• Other duties as assigned
Minimum Requirements
Education • BS, MS or PhD degree in a scientific discipline
Experience • 5-7 with Bachelor's OR 4-6 with Master's OR 3-5 with Ph.D. in a biotechnology field, with at least 3 years in Regulatory Affairs.
• Experience working with biologic and/or gene therapy products preferred
Licenses or Certifications
• RAPS certification preferred, but not required
Knowledge & Skills
• Knowledge of GCP, GLP, GMP and FDA and ICH guidelines
• Understanding/working knowledge of Microsoft applications (eg, Word, Excel, PowerPoint, Outlook, SharePoint), and Adobe Acrobat
• Veeva Vault RIM experience with eCTD structure
• Strong interpersonal, negotiating and problem-solving skills
• Excellent communication skills, both written and verbal
• Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches
• Strong organizational skills, eg, file and data management
• Excellent project management skills
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Neurogene's business, this description is subject to change and may be modified at any time, whether formally or informally.
