Head of Regulatory Affairs, Europe

Summary of Position

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at and and on LinkedIn.

Position 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

Candidate 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%)

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees