Head of Regulatory Affairs, Europe

Head Of Regulatory Affairs, Europe

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.

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 :

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