General Scope and Summary
Q32 Bio is searching for an independent, collaborative Regulatory specialist to assist the with regulatory operations across the company. The Manager/Associate Director, Regulatory will play a critical role in operationally executing on the regulatory tasks that lead to approvals of our products. They will be responsible executing strategy and plans for the day to day regulatory submissions and maintenance of regulatory tasks. 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
- Represent Regulatory Affairs on multi-disciplinary project teams and provide regulatory guidance on development plans for our inflammatory and autoimmune programs.
- Prepare regulatory development plans for assigned projects and establish/manage regulatory timelines
- Ensure effective and timely execution of US and Global regulatory filings in compliance with relevant standards and commitments
- Assist in the planning, preparation, and review of content for submissions to Regulatory Agencies (eg, INDs, IMPDs, CTAs, meeting requests, IND/BLA safety reports, annual reports) and coordinate responses to Regulatory Agency requests
- Assist with meeting request/briefing document preparation, responses to pre-meeting comments, preparing teams for meetings and teleconferences with Regulatory Agencies
- Performs quality review of regulatory requirements for CMC, preclinical and clinical submissions and programs to assure that all development activities are in compliance with applicable regulations and guidelines
- Develop and maintain knowledge of US and EX US regulations as appropriate for the assigned program(s)
- Help keep cross-functional team members apprised of new regulations, standards, policies, and guidances /guidelines issued by Regulatory Agencies that may impact the company
- Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
- Participate in initiatives aimed at improving internal standards and systems
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.
- Minimum of a B.S. in a scientific discipline required
- Must have 5+ years of biotech experience in regulatory affairs in multiple phases of development
- 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