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 and follow and on .
Summary of Position:
Reporting to the Senior Director, Regulatory Operations, the Senior Manager, Regulatory Operations will be a key contributor to Scholar Rock’s Regulatory Operations and Regulatory Affairs teams with accountability for submission activity by supporting cross-functional departments. Primary responsibilities are submission management activities and regulatory information management including but not limited to Word document processing/formatting, template development, PDF publishing and review, eCTD Publishing, review and archiving consistent with global regulatory requirements for different application types.Position Responsibilities: Partner with Regulatory Affairs Lead(s), subject matter experts, and cross functional departments to plan, prepare and publish global health authority submissions. (eg, IND, NDA/BLA, MAA, Swissmedic, CTA, NDS).Manage submission deliverables, according to timelines, within Veeva RIM; ensure accuracy and consistency across regulatory submission documents following the regulatory style guide (advanced editing/formatting support of submission documents and document-level publishing).Coordinate activities with external publishing vendor and consultants for timely delivery of high-quality regulatory submissions to global health authorities. Archive global regulatory submissions and health authority communications and maintain health authority question and commitment records within Veeva RIM. Provide technical expertise and guidance to cross-functional teams on format, style, and structure of documents for electronic submissions to ensure compliance with submission standards and processes.Lead and contribute to Regulatory Operations initiatives (process changes and system implementations/enhancements); recommend and help implement associated process improvements. Other duties as assigned.Candidate Requirements:Bachelor’s degree and 6+ years of experience in Regulatory Operations in a biotech/pharmaceutical industryIn depth, hands-on experience in MS Word processing, formatting, and PDF publishing for electronic submissions (experience with StartingPoint templates and TRS/ISI Toolbox preferred).Experience with electronic document management and publishing systems (e.g., Veeva Vault RIM, SharePoint)Experience with compiling/publishing global eCTD submissions with Veeva Vault RIMDemonstrated knowledge of current CTD/eCTD format and global regulatory submission requirements. Proficiency with MS Word and Adobe is a must. Knowledge of MS Outlook, PowerPoint, Smartsheet and Excel a plus.Strong attention to detail and the ability to multi-task in fast paced environmentCommitted to producing high quality and timely deliverables.Ability to work independently as well as part of a team and with external partnersExcellent organizational and communication skills, both written and verbalPositive attitude, flexible, patient and proactiveScholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.