Director/Sr. Director, Regulatory Strategy

Cambridge · CambridgeFull-Timesenior

Legal & ComplianceOtherRegulatory

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Quick Summary

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.

Technical Tools

Legal & ComplianceOtherRegulatory

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 ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is responsible for the development and implementation of the Global Strategy for assigned clinical and/or pipeline programs globally depending on the program. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence.

Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success.

Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (<2 years old) program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements in the region.

Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (<2 years old)

Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan

Lead and managing regulatory interactions on assigned programs, building trusted relationships with regulatory authorities

Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., Module 1, briefing documents)

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

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

Partner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial plan

Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., DRC, program teams, clinical development teams, study teams)

Maintain currency of 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

Provide support to local regulatory experts

Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

Education in life sciences required

Greater Boston-based with ability to be regularly present in the Cambridge, MA office

7+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of EU regulatory requirements

Demonstrated experience of leading successful engagement with EMA

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

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 and environment

Ability to travel domestically and internationally (~10%)