Regulatory Affairs Associate

Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF-ß signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.

As a member of the Regulatory team, the Regulatory Associate will contribute to the progress of products in clinical development by supporting regulatory lead(s) with major filings (INDs, CTAs, NDAs, MAAs) and working collaboratively with cross-functional teams to support development milestones. The Regulatory Associate will also contribute to regulatory affairs initiatives aimed at improving internal standards and systems.

Primary Responsibilities:

• Contribute to the preparation of regulatory submissions including INDs, CTAs, annual reports, briefing packages.
• Responsible for supporting active INDs and CTAs including planning for and coordinating IND maintenance submissions and CTA amendments.
• Contribute, in collaboration with regulatory lead, to develop response strategy to address agency queries and information requests
• Manage and coordinate with regulatory CROs for submission of high-quality documents to support ex-US submissions
• Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards
• Support regulatory leads and contribute to the implementation of nonclinical, and clinical regulatory strategies for projects in all stages of development (pre-IND through commercial) for assigned projects. Maintains awareness of applicable regulations
• Support preparation for Health Authority interactions
• Responsible for contributing or developing and maintaining project timelines and the planning of regulatory milestones
• Contribute and establish relevant processes and procedures to support activities of the Regulatory Affairs function and review/liaise with cross-functional departments on SOPs/Work Instructions/initiatives
• Maintain regulatory archives and submission trackers.
• Ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements
• Stay informed about changes in regulatory requirements and industry standards, and disseminate relevant information to team members
• Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration
• Stay informed about changes in regulatory requirements and industry standards, and disseminate relevant information to team members
• Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration.
  
  
  

Qualifications:

• Bachelor's Degree, Master’s in Regulatory Affairs, preferred
• Minimum of 1-2 years of experience in clinical research, with a focus on regulatory affairs and compliance
• Strong understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standards
• Experience/understanding/use of Microsoft software tools
• Exceptional attention to detail and organizational skills
• Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams
• Ability to work independently and collaboratively in a fast-paced environment
  
  
  

Our Diversity, Equity & Inclusion Mission Statement:Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.