Scholar Rock is a Phase 3, clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
The Regulatory CMC Director will provide strategic and operational leadership to support development and execution of CMC strategies across product lifecycles. The position will manage regulatory CMC activities, submissions and interactions with FDA and other regulatory agencies for CMC issues.
Provide regulatory support, guidance and expertise to internal groups such as Technical Operations, QC and QA to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs so that products are developed and manufactured in compliance with appropriate regulations and guidelines.
Accountable for leading the development and implementation of the regional or global regulatory CMC strategy for a product/group of products. Ensure that the strategy is designed to support accelerated regulatory pathways as applicable.
Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.
Review and approve technical documentation to ensure compliance with regulations and existing regulatory submissions.
Provide regulatory CMC guidance to project teams.
Manage complex projects, timelines and teams in a matrix team environment.
Participate in regulatory infrastructure and capability building, including development of processes and procedures.
BS, MS or PhD in a science related field. Minimum of 10 years experience in the pharmaceutical industry with a minimum of 7 years in CMC regulatory affairs and a strong biologics background.
Ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
Previous demonstrated experience with major Health Authority interactions. Prior experience with Phase 3 or commercial biologics is strongly desired. Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development.
The ability to think strategically and critically and evaluate risks to regulatory activities.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.