Director, Regulatory Operations

Director, Regulatory Operations

Lexington, MA (Hybrid)

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 Head Regulatory Affairs, the Director of Regulatory Operations will be responsible for establishing the Regulatory Operations role at Keros. This individual will leverage their extensive knowledge of Regulatory Operations to support Keros' growing regulatory needs including inhouse publishing as well as working with multiple external vendors.

Primary Responsibilities:

• Oversee all Regulatory Operations deliverables, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault Regulatory Information Management system, submission management, and training of associated business processes
• Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM
• Manage user groups and workflows and create and maintain archives of Health Authority interactions
• Develop, manage, and distribute reports, dashboards, and templates to meet user needs
• Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management
• Partner with IT and Quality to support system validation activities
• Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM
• Provide eCTD/CTD publishing services including rendering, bookmarking, hyperlinking, compilation, table of contents creation and QC regulatory submissions to Regulatory agencies
• Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, BLA, etc.)
• Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
• Create, update and maintain submission templates that meet global regulatory requirements

Qualifications:

• BA/BS or equivalent experience
• At least 12+ years of industry experience with at least 7+ years experience in regulatory operations
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Prior experience running large scale RA projects within the biotech industry
• Extensive knowledge of eCTD, e-publishing systems for preparing regulatory submissions as well as regulatory management systems (e.g. Veeva RIM)
• Experienced in MS Word, Excel, PowerPoint, and Adobe Acrobat, Veeva Vault RIMs
• Ability to thrive in a collaborative and fast-paced team environment

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.

Potential base pay range

$206,000 - $227,000 USD

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.

Recruitment & Staffing Agencies: Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.