Senior Associate, Regulatory Operations

Job Description

• Performs moderately complex to non-routine submission publishing activities associated with generating electronic submission-ready documents and aggregated reports. • Prepares a variety of moderately complex submissions using publishing applications and associated publishing tools in accordance with company and industry regulations. • Utilizes systems and tools for electronic document capture, generation, and QC. • Ensures final document components are electronically archived according to the departmental practices. • May represent Regulatory Operations by taking the lead in submission planning and report level process meetings. • Participates in the development or upgrading of templates as well as guidance. • Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives. • May interface with cross-functional teams and or content authors to discuss routine submission preparation and content. • May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures. • Identifies and records issues that require resolution prior to finalization and liaises with responsible author to resolve issues. Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented and meet electronic submission requirements. • Exercises judgment within well-defined procedures and practices to determine appropriate action.

Qualifications

• BA or BS degree with 5+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred. • Experience in successfully working in a fast-paced environment with tight timelines, large deliverables. • Strong understanding of regulations related to electronic records and electronic signature (21 CFR Part 11) • Must be able to master new technical skills and apply them to projects as the industry, and the company, evolves. • Must demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines as well as to work overtime in order to meet required timelines. • Must have a strong working knowledge and understanding of MS Office tools with advanced skills specifically in MS Word and templates, Adobe Acrobat Pro, ISI ToolBox, eCTD validation software, Veeva Vault RIM for Submissions and DocuBridge Publisher. • Works well under general direction and may independently determine and develop approaches to non-routine problems. • An excellent understanding of regulatory procedures, filing requirements and publishing is required. #LI-CS1 #LI-Hybrid #LI-Remote

Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans