Head of Regulatory Affairs, Europe

Overview

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, 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 ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position

The Head of Regulatory Affairs, Europe, is a leadership position that will be responsible for building and leading the regulatory team to develop and implement regulatory strategies to secure and maintain market access for product(s) in line with business objectives and in coordination with key internal stakeholders. The Head of Regulatory Affairs, Europe, ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team and partners with the European business. The role would also develop regulatory strategy, oversee the filings and manage reviews for gaining market access for the Rest of World.

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.

Qualifications

- 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.

#J-18808-Ljbffr