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Director, Regulatory Affairs
1 month ago
Join our Team at Entrada Therapeutics
Entrada Therapeutics is on a mission to revolutionize the world of biopharmaceuticals by developing a new class of medicines that target intracellular areas that were previously thought to be unreachable.
Our cutting-edge EEVTM-therapeutics are designed to deliver a wide range of treatments into various organs and tissues effectively, improving the overall effectiveness of the treatment. At Entrada, we are dedicated to developing RNA-, antibody-, and enzyme-based programs to potentially treat conditions such as neuromuscular, ocular, metabolic, and immunological diseases, among others.
Join our passionate team of experts dedicated to making a real difference in the lives of patients and their families.
Director of Regulatory Affairs Position at Entrada
Entrada is seeking a resourceful and collaborative professional to join our dynamic Regulatory Affairs team. As the Director, you will play a vital role in developing and implementing innovative regulatory strategies to advance our pipeline of intracellular therapeutics for various diseases. Reporting directly to the Senior Vice President of Regulatory Affairs, you will lead the charge in ensuring compliance with global regulations and guidelines while working closely with cross-functional teams.
This role is pivotal to the success of our Regulatory department and development teams. If you have a history of contributing to regulatory strategies in the biotech or pharmaceutical industry, working effectively with diverse teams, and are eager to take on a leadership position in a fast-paced environment, we want to hear from you.
Responsibilities
- Contribute to global regulatory strategy development for preclinical and clinical stages.
- Identify regulatory opportunities and risks, finding innovative solutions to challenges.
- Lead the development of regulatory strategies for rare disease treatments.
- Manage the submission process for IND and CTA submissions.
- Cultivate relationships with regulatory agencies and external partners.
- Establish a top-tier Regulatory Affairs department.
- Inspire and lead colleagues and direct reports to excellence.
Requirements to Excel in this Role
- Demonstrated experience with regulatory submissions (IND, CTA, NDA, BLA, MAA).
- Deep understanding of global regulations, health authorities, and drug development processes.
- Background in rare diseases, pediatrics, or neuromuscular therapeutics is preferred.
- Strong communication, organizational, and interpersonal skills.
- Proactive, self-motivated, and able to work independently.
- Minimum of 10 years in Regulatory Affairs.
Why Join Entrada
At Entrada, we offer competitive health benefits, life insurance, 401(k), and more to ensure our team's well-being. Enjoy discretionary time off, a vibrant work environment located in Boston's Seaport District, and the opportunity to be part of a team dedicated to making a difference.
Entrada Therapeutics is an equal opportunity employer committed to diversity in the workplace.
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