Scholar Rock
Sr. Director, Regulatory Strategy
Cambridge, MA · Director
Sponsorship not specified$200k-$300kDetected 128 days ago
Business DevelopmentFDA RegulatoryRegulatory Affairs
About the role
- As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures.
- Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
- 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.
Responsibilities
- 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)
- Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
- Partner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial plan
- Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
- Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
Compensation
- $200k-$300k
Benefits
- 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
Company info
- Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases.
- Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity.
- Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases.
Equal opportunity
- Scholar Rock is an Equal Opportunity Employer.
Apply directly at Scholar Rock →Create a free account for alerts like thisView Scholar Rock immigration profile
This listing is sourced directly from Scholar Rock's careers page and normalized into a canonical job model.