Scholar Rock is hiring a
Director/Senior Director

Summary

The Director/Senior Director, EU Regulatory Strategy will be responsible for developing and implementing the EU regulatory strategy for assigned clinical programs at Scholar Rock. The role requires a candidate with education in life sciences, 7+ years of experience in the biopharmaceutical industry, demonstrated experience engaging with EMA, strong leadership skills, and the ability to travel domestically and internationally.

Requirements

• Education in life sciences required
• 7+ years of experience in biopharmaceutical industry with deep understanding of EU regulatory requirements
• Demonstrated experience of leading successful engagement with EMA
• Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
• 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%)

Responsibilities

• Serve as a thought leader on regulatory affairs, defining European regulatory strategy and plan to maximize regulatory success
• Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements
• Lead MAA review, including response to List of Issues and EU-SmPC negotiations
• Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
• Serve as point of contact with EMA leading and managing regulatory interactions, building trusted relationships with regulatory authorities
• Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., MAA module 1, briefing documents, DSUR)
• Lead response to EU CTR questions to support clinical trials in EU5
• Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
• Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
• Provide regulatory input and support for business development activities
• Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
• Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., PRC, program teams, clinical development teams, study teams)
• Maintain currency of EU regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
• Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance

Preferred Qualifications

Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required