Director/Senior Director Regulatory Affairs

General Scope and Summary

Q32 Bio is searching for a strategic, collaborative regulatory leader who will provide regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures developments of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.  The qualified person will play a critical role developing the strategy and executing on the the day to day operations of the Regulatory function for one of our programs including leading cross-departmental teams.  To be successful in this role the individual must have strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.

Roles and Responsibilities

• Provides strategic regulatory leadership and guidance to the project teams. Designs programs for complete and accurate US and EX US IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
• Provides regulatory expertise and support for nonclinical, clinical, and commercial areas for investigational and marketed products. Ensures developments of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes.
• Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval. Works closely with Program Management, CMC, Clinical Operations and Research teams to develop timelines, and clear instructions on what is needed for regulatory submissions.
• Provides strategic regulatory leadership and guidance to the project teams. Designs programs for complete and accurate IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
• Defines regulatory expectations for teams, identifies elements of INDs and FDA required preparation (and other Health Authorities in collaboration with regional regulatory affairs), positions response to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
• Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented.
• Oversees the submission of product registration of new drugs, progress reports, supplements, amendments, and periodic adverse experience reports. Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA to assure compliance with regulatory standards.
• Oversee the review of documents/reports generated by RA support staff or contractors or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end.
• Responsible for management, monitoring, oversight, strategic development, and global labeling approvals.
• Recruits, trains, and coaches staff; evaluates employee performance on an ongoing basis, and completes annual performance reviews as appropriate.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a rapid moving, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management skills and ability to identify issues and raise to key stakeholders. Ability to see plans all the way through to completion and work within a cross-departmental team.

Basic Qualifications

• Minimum of a M.S. in a scientific discipline required, Phd Preferred
• Must have 10+  years of biotech experience in regulatory affairs in multiple phases of development
• Comprehensive knowledge of the drug development process, drug laws, global
  regulations and guidelines.
• Comprehensive understanding of global regulatory agencies.
• Proven success of submitted sNDA, IND and NDA.
• Full functional knowledge of regulatory requirements (regulations, directives, and guidances/guidelines) pertaining to the development and registration of drug products in multiple ICH regions
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Must be able to solicit information, persuade others and shape outcomes.
• Strong team player that is solution oriented.
• Knowledge of Clinical, Nonclinical and CMC regulatory issues