Vice President, Regulatory Affairs

Keros Therapeutics•Lexington, MA

About The Position

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary Reporting to the CMO, the ideal candidate will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. Represent the company with domestic and international regulatory authorities, contractors, and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.

Requirements

Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs
Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project
Solid knowledge of GCPs and GLPs
Direct experience in interfacing with relevant regulatory authorities
Experience working in a small biotech company environment for 5+ years
Regulatory experience in rare/ultra-rare diseases
Demonstrate excellent leadership and communication skills
Demonstrate strong organizational skills, including the ability to prioritize personal workload
Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
Experience with eCTD, e-publishing systems for preparing regulatory submissions
BA/BS degree in a scientific/engineering discipline required; Masters or PhD preferred.
Minimum of 12 years of regulatory experience in biotech, pharma, or clinical research organizations, with 10+ years in regulatory strategy

Responsibilities

Direct Keros’ global clinical, non-clinical, and CMC regulatory strategies
Provide regulatory guidance throughout the development process
Oversee clear and effective regulatory submissions on behalf of Keros leveraging internal and external resources
Oversee meetings with regulatory bodies to include but not limited to Pre-IND meetings, Type C meetings, EOP meetings, pre-NDA meetings, and EU Scientific Advice
Build and maintain excellent relationships with relevant regulatory agencies
Review, analyze and translate regulatory requirements into a workable deliverable for project meetings, senior and executive management decisions
Supervise, interact with and/or coordinate with regulatory team and external service providers to ensure adequacy of project support and deliverables
Supervise, review, and edit regulatory documents and packages for submissions to national regulatory authorities (NRAs) and/or scientific or executive management meetings
Build the Regulatory and Medical Writing functions that can support clinical trials to product registration
Conversant with all aspects of the external regulatory environment, including upcoming regulations and regulatory positions, thereby providing the company with the necessary regulatory technical expertise and counsel to ensure success in developing its products
Review and edit, as appropriate, press releases, presentations for external meetings