Regulatory Affairs Co-Op - Keros Therapeutics
Lexington, MA
About the Job
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.
Keros Therapeutics is seeking a motivated and detail-oriented Regulatory Affairs Co-Op to join our Regulatory Team. As a member of the Regulatory team, the Regulatory Co-Op will shadow Regulatory team members and contribute to the progress of products in clinical development by supporting major filings (INDs, CTAs, NDAs, MAAs) and working collaboratively with cross-functional teams to support development milestones. The Regulatory Co-Op will also contribute to Regulatory Affairs initiatives aimed at improving internal standards and systems. This role offers a unique opportunity to gain hands-on experience in Regulatory Affairs and contribute to the development and approval of novel treatments for high unmet medical need hematological and musculoskeletal disorders.
Primary Responsibilities:
- Shadow Regulatory team members and contribute to the preparation of regulatory submissions including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), Annual reports, Briefing packages.
- Support active INDs and CTAs, including planning for and coordinating IND maintenance submissions and CTA amendments.
- Attend team meetings with Regulatory team members, as applicable, to assist in strategic discussions to build team collaboration skillset.
- Contribute, in collaboration with regulatory team members, to the development and preparation of response strategies to address Agency queries and information requests.
- Assist in developing and maintaining project timelines to ensure regulatory milestones are met on time.
- Maintain accurate and up-to-date regulatory files and documentation in Regulatory Archives and submission trackers, ensuring completeness and compliance with regulatory standards.
- Provide administrative support to the Regulatory Affairs team, including scheduling meetings, preparing presentations, capturing meeting minutes and other tasks as needed.
- Assist in maintaining documents within the Veeva Regulatory Information Management (RIM) systems, ensuring proper organization and compliance.
- 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
Qualifications:
- Currently enrolled in a Bachelor's or Master's degree program in a related field or equivalent, such as Life Sciences, Pharmacy, Chemistry, or Regulatory Affairs.
- Strong interest in Regulatory Affairs.
- Exceptional attention to detail and organizational skills.
- Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams.
- Experience/understanding/use of Microsoft software tools.
- Ability to work independently and collaboratively as part of a team.
- Ability to manage multiple tasks and prioritize effectively.
- Understanding of regulatory requirements and guidelines is a plus.
- Prior Co-Op or Intern Experience preferred.
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.