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.
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