Scholar Rock
Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a
51 - 200 employees
Founded 2016
đź’° $205M Post-IPO Equity on 2022-06
Head of Regulatory Affairs
Job not on LinkedIn
September 25
Scholar Rock
Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a
51 - 200 employees
Founded 2016
đź’° $205M Post-IPO Equity on 2022-06
đź“‹ Description
• 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 Europe and the Rest of World • Regulatory Intelligence: gather and analyze regulatory intelligence to anticipate changes in the regulatory landscape and communicate impacts to the business and global partners • Manage project assignments and oversee CTR for investigational programs • Ensure all regulatory and compliance activities across Europe are effectively managed, supporting distribution, R&D, and marketing of products • Lead the European Regulatory Affairs team and partner with the European business
🎯 Requirements
• 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%)
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