Posted:
11/15/2024, 8:48:51 AM
Location(s):
Massachusetts, United States ⋅ Waltham, Massachusetts, United States
Experience Level(s):
Senior
Field(s):
Legal & Compliance
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
Minimum Qualifications
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.
Website: https://affiniatx.com/
Headquarter Location: Waltham, Massachusetts, United States
Employee Count: 51-100
Year Founded: 2019
IPO Status: Private
Last Funding Type: Series B
Industries: Biotechnology ⋅ Health Care ⋅ Life Science ⋅ Therapeutics