Manager Regulatory Affairs Operations
Job title: Manager Regulatory Affairs Operations in San Diego, CA - Princeton, NJ at Acadia Pharmaceuticals
Company: Acadia Pharmaceuticals
Job description: Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThe 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-quality, technically valid submissions in alignment with health authority guidelines and industry best practices. This individual will have a clear understanding of electronic submission requirements including the eCTD structure, Word templates and styles.Primary Responsibilities
Using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions in alignment with health authority guidelines and industry best practices.
For authored documents, provide guidance on formatting and review for adherence to Acadia's Style Guide
Perform document verifications and follow procedures to identify, document, and communicate findings
Manage document management tasks including file transfer, storage, tracking, and archival services
Provide training to cross functional teams on Acadia style guide and Acadia 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 transmit submissions to FDA and other Health Authorities
Update trackers, correspondence logs, metrics on daily/weekly/monthly basis as internal policies dictate
Other activities as designated
Education/Experience/Skills
Requires a Bachelor's degree in Business Administration, Life Science discipline or related 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 Veeva VAULT RIM authoring workflows, document metadata, and naming conventions
Strong working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Word, Acrobat, DXC Toolbox, 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 related 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 reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move 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
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Company: Acadia Pharmaceuticals
Job description: Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThe 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-quality, technically valid submissions in alignment with health authority guidelines and industry best practices. This individual will have a clear understanding of electronic submission requirements including the eCTD structure, Word templates and styles.Primary Responsibilities
Using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions in alignment with health authority guidelines and industry best practices.
For authored documents, provide guidance on formatting and review for adherence to Acadia's Style Guide
Perform document verifications and follow procedures to identify, document, and communicate findings
Manage document management tasks including file transfer, storage, tracking, and archival services
Provide training to cross functional teams on Acadia style guide and Acadia 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 transmit submissions to FDA and other Health Authorities
Update trackers, correspondence logs, metrics on daily/weekly/monthly basis as internal policies dictate
Other activities as designated
Education/Experience/Skills
Requires a Bachelor's degree in Business Administration, Life Science discipline or related 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 Veeva VAULT RIM authoring workflows, document metadata, and naming conventions
Strong working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Word, Acrobat, DXC Toolbox, 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 related 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 reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move 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 Now