Head of Regulatory Affairs, Europe
Scholar RockPosted September 25, 2025
Full Time
About the Company
Scholar Rock is a biopharmaceutical company specializing in discovering and developing innovative therapies for serious diseases with high unmet needs. Focused on the biology of transforming growth factor beta (TGFβ) superfamily proteins, Scholar Rock has created a pipeline targeting neuromuscular disease, cardiometabolic disorders, cancer, and other conditions. The company is distinguished by its proprietary platform that develops novel monoclonal antibodies for precise protein growth factor modulation, offering transformative treatments like muscle-targeted therapies for spinal muscular atrophy (SMA).
Job Description
Scholar Rock is seeking a Head of Regulatory Affairs, Europe to lead their regulatory team in developing and implementing strategies to secure and maintain market access for products across Europe. The role involves managing regulatory and compliance activities, overseeing filings, and ensuring compliance with national regulations. The company focuses on developing transformative therapies for rare diseases, particularly neuromuscular disease and cancer.
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)
- Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases
- Demonstrated reputation as a well-respected, dynamic team leader
- Strong written, verbal communication skills and interpersonal skills
- Ability to travel domestically and internationally
