Senior Manager, Regulatory Operations

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:

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 industry
• In 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 RIM
• Demonstrated 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 environment
• Committed to producing high quality and timely deliverables.
• Ability to work independently as well as part of a team and with external partners
• Excellent organizational and communication skills, both written and verbal
• Positive attitude, flexible, patient and proactive