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