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 planningProvide expert guidance, direction, and leadership on those strategies to the development team and senior management in a collaborative mannerOversee regulatory filings (IND, BLA, etc.) including authorship of critical documents as neededPrepare and execute all meeting requests and briefing documents. Coordinate and prepare teams for Health Authority meetingsInterface with regulatory authorities and serve as the primary liaison with regulatory authorities for day-to-day interactionsMaintain current working knowledge of US and EU laws, regulations, and guidelines as well as familiarity with the global regulatory environmentIdentify and collaborate with regulatory experts and consultantsCoordinate and prepare responses to requests for information from regulatory authoritiesRepresent the regulatory function on cross-functional development team(s)Establish, update, and implement regulatory policies, standards, and procedures for the companyEnsure operations are compliant with FDA, ICH, EMA, and industry standardsManage the regulatory aspects of products and projects including achievement of timelines and deliverablesHire, train and lead the regulatory affairs team to support the growing pipelineCreate and manage team budget and resource planningMinimum Qualifications Advanced degree in a relevant disciplineExperience in Gene Therapy preferredExperience with small population indications (e.g., rare disease or cardiology) preferred10-15 yrs of regulatory affairs experience within Biotechnology industry or equivalent experienceDirect management experience in leading a regulatory affairs teamStrong strategic leadershipExperience setting global regulatory strategyEqual 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.
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