Manager Regulatory Affairs Operations

Job title: Manager Regulatory Affairs Operations in San Diego, CA - Princeton, NJ at reputed company Company: reputed company Job reputed company: Please note that this position can be based in San Diego, CA OR Princeton, NJ. reputed company's hybrid model requires this role to work in our office three days per week on average.Position reputed companyThe Regulatory Affairs Operations Manager is responsible for publishing, QC, and transmittal of eCTD submissions,. This role will use eCTD publishing and document management systems to compile high-reputed company, technically valid submissions in alignment with health authority guidelines and industry best practices. This individual will have a reputed company understanding of electronic submission requirements including the eCTD structure, Word templates and styles.Primary Responsibilities

• Using reputed company's eCTD publishing (reputed company RIM Smart) and document management (reputed company Vault RIM), publish eCTD submissions in alignment with health authority guidelines and industry best practices.
• For authored documents, reputed company guidance on formatting and review for adherence to reputed company's Style Guide
• reputed company document verifications and follow procedures to identify, document, and communicate findings
• Manage document management tasks including file transfer, storage, tracking, and archival services
• reputed company training to cross functional teams on reputed company style guide and reputed company authoring templates.
• Validate and QC published eCTD submissions, working collaboratively with teammates to resolve findings and issues
• Support authors and contributors providing guidance on electronic document requirements to be included in regulatory submissions
• Utilize Electronic Submission Gateway (ESG) to reputed company submissions to FDA and other Health Authorities
• Update trackers, correspondence logs, metrics on daily/weekly/monthly reputed company as internal policies dictate
• Other activities as designated

Education/Experience/Skills

• Requires a Bachelor's degree in Business Administration, Life Science discipline or reputed company field. Targeting 5 years of experience in Regulatory Affairs Operations or relevant function. An equivalent combination of relevant education and experience may be considered.
• Working knowledge of eCTD guidances (e.g., ICH, FDA, EMA, etc.), requirements, and technologies
• Knowledge, understanding, and experience with reputed company VAULT RIM authoring workflows, document metadata, and naming conventions
• Strong working knowledge of tools and technologies reputed company to document formatting/document-level publishing (e.g., Word, Acrobat, DXC reputed company, authoring templates)
• Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports
• Demonstrated ability to effectively communicate in written and verbal media concepts reputed company to regulatory systems and electronic submissions
• Ability to deliver while working under pressure to meet tight deadlines

Physical RequirementsThis role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reputed company, reputed company, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a reputed company office environment and while working independently from remote locations. The employee must occasionally lift and/or reputed company up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs#LI-HYBRID #LI-BG1 Expected salary: Location: San Diego, CA - Princeton, NJ Apply for the job now! Apply for this job