Scholar Rock · 3 months ago
Head of Regulatory Affairs, Europe
United States
Full-time
Remote
Senior Level, Lead/Staff
15+ years expScholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. The Head of Regulatory Affairs, Europe, will lead the regulatory team to implement strategies for market access and ensure compliance with regulations across Europe, while also managing relationships with regulatory agencies.
BiopharmaBiotechnologyMedicalTherapeutics
Responsibilities
Establishes, develops, and manages effective/high-performance regulatory teams both via direct and indirect reporting structure
Applies extensive knowledge of drug development and regulatory requirements both strategically and operationally to development projects and marketed products to support corporate goals
Establishes and maintains a trusting relationship with Regulators and ensures compliance with national regulations
Develop regulatory strategy, oversee the filings and manage reviews for gaining market access for the Rest of World
Regulatory Intelligence: The Head gathers and analyzes regulatory intelligence to anticipate changes in the regulatory landscape and communicate these impacts to the business and global partners
Manage project assignments and oversee CTR for investigational program
Qualification
Required
15+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development
Demonstrated experience of leading successful engagement with key regulatory agencies (e.g., FDA and EMA) from preclinical through global approvals and post marketing required
Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred
Demonstrated reputation as a well-respected, dynamic team leader with strong leadership
Strong written, verbal communication skills, and interpersonal skills
Capable of managing shifting priorities in a rapidly changing environment
Ability to travel domestically and internationally (~10%)
Preferred
Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred
Company
Scholar Rock
Scholar Rock is a biopharmaceutical company that develops and discovers new medicines and treatments for the serious diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$743MKey Investors
InvusFidelityARCH Venture Partners
2024-10-08Post Ipo Equity· $300M
2023-10-11Post Ipo Equity· $85M
2022-06-17Post Ipo Equity· $205M
Leadership Team
Jay Backstrom
Chief Executive Officer
Recent News
Business Wire
2026-01-12
Morningstar.com
2025-12-13
Company data provided by crunchbase