Keros Therapeutics · 18 hours ago
Director, Regulatory Affairs Strategy
Lexington, MA (Hybrid)
Full-time
Hybrid
Director/Executive
$188K/yr - $230K/yr
10+ years expKeros is focused on delivering significant clinical benefits to patients with disorders linked to dysfunctional signaling of the TGF-β family of proteins. The Director of Regulatory Affairs Strategy will develop and implement global regulatory strategies for unique products addressing hematological, pulmonary/cardiovascular, and obesity/neuromuscular disorders, ensuring effective communication with health authorities and cross-functional teams.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Provide regulatory strategic leadership for drug development projects, including but not limited, to health authority interactions, regulatory submissions, and other regulatory requirements in line with corporate objectives and timelines
Serve as an influential and well-respected spokesperson with staff at FDA/EMA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
Provide de-risking development strategies and evaluating opportunities to accelerate development
Provide leadership and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities in support of INDs, CTAs, IMPDs, PIPs, BLAs, MAAs as well as Fast Track, Breakthrough, ODD, amendments, safety reports, and annual updates, as applicable
Interpret and communicate regulatory expectations to internal and external stakeholders to execute program objectives in compliance with applicable regulations
Contribute to the strategic leadership and development of policies, procedures, and best practices commensurate with the requirements of a rapidly growing company
Participate in regulatory intelligence activities, monitor advisory committees, regulatory guidelines and trends
Ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements
Qualification
Required
Requires a MS degree (PharmD, or PhD preferred) with a minimum of 10 years of experience in the biotech/pharmaceutical industry, with a minimum of 8 years of experience within regulatory affairs
Strong knowledge of FDA and EU regulations
Prior experience with FDA and EMA, and success with filing INDs/CTAs/BLAs/NDAs/MAAs
Experience with both early and late-stage drug development
Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
Experience required with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages, PIPs and documents for other regulatory submissions
Experience interacting directly with the FDA/EMA and other health authorities
Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
Strategic thinker who can balance near term objectives with long term goals and outcomes
Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
Ability to thrive in a collaborative and fast-paced team environment
Preferred
Experience with biologics drug development is desirable
Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus
Company
Keros Therapeutics
Keros is a clinical-stage biopharmaceutical company focusing on the discovery, development, and commercialization of novel treatments.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$379.5MKey Investors
Pontifax
2024-01-03Post Ipo Equity· $140M
2020-11-13Post Ipo Equity· $149.5M
2020-04-07IPO
Leadership Team
Lorena Lerner
Chief Scientific Officer
Recent News
Keros Therapeutics, Inc.
2025-11-21
2025-11-20
Keros Therapeutics, Inc.
2025-11-19
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