Head of Global Regulatory Affairs

Affinia Therapeutics is an innovative gene therapy company with a vision to create a paradigm shift by broadening the reach of gene therapy to prevalent diseases. Our proprietary Affinia Rationally-designed Therapies (ART) platform was created to address key efficacy, safety, and cost of goods limitations of conventional gene therapies. We are backed by a strong syndicate of life science investors. Our purpose is to have a dramatic impact on the lives of patients around the world.

You will play a key role in shaping our culture and embodying our values of integrity, passion, and teamwork. You will be working alongside the founding management team who have a track record of success in the industry. The pace of work is dynamic, fast, and fun.

We offer competitive salary and benefits with the ability to make a difference.

Position Summary

As Head of Global  Regulatory Affairs (job level will commensurate with experience), you will oversee and drive the U.S. and Global regulatory strategy for  Affinia Therapeutics.

You will partner closely with cross functional leadership, offering regulatory guidance, regulatory risk advice, and leading interactions with regulatory agencies on behalf of Affinia Therapeutics. Working closely with Manufacturing, Translational Science and Quality functions, you will lead all aspects of the regulatory development strategy,  planning and executing program applications from CMC to Clinical.

This position is based out of our state-of-the-art facility in Waltham, MA with at least 3 days per week in the office.

 Primary Responsibilities

• Develop and execute robust US and global regulatory strategies (clinical, non-clinical, CMC) for pipeline planning
• Provide expert guidance, direction, and leadership on those strategies to the development team and senior management in a collaborative manner
• Oversee regulatory filings (IND, BLA, etc.) including authorship of critical documents as needed
• Prepare and execute all meeting requests and briefing documents. Coordinate and prepare teams for Health Authority meetings
• Interface with regulatory authorities and serve as the primary liaison with regulatory authorities for day-to-day interactions
• Maintain current working knowledge of US and EU laws, regulations, and guidelines as well as familiarity with the global regulatory environment
• Identify and collaborate with regulatory experts and consultants
• Coordinate and prepare responses to requests for information from regulatory authorities
• Represent the regulatory function on cross-functional development team(s)
• Establish, update, and implement regulatory policies, standards, and procedures for the company
• Ensure operations are compliant with FDA, ICH, EMA, and industry standards
• Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
• Hire, train and lead the regulatory affairs team to support the growing pipeline
• Create and manage team budget and resource planning

Minimum Qualifications

• Advanced degree in a relevant discipline 
• Experience in Gene Therapy preferred
• Experience with small population indications (e.g., rare disease or cardiology) preferred
• 10-15 yrs of regulatory affairs experience within Biotechnology industry or equivalent experience
• Direct management experience in leading a regulatory affairs team
• Strong strategic leadership
• Experience setting global regulatory strategy

Equal Opportunity Employer

Affinia is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.