Manager Regulatory Affairs Operations
Manager Regulatory Affairs Operations
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Please note that this position can be based in San Diego CA OR Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.
Position Summary
The 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 Acadias 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 Acadias 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 Bachelors 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 Requirements
This 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
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Required Experience:
Manager
Employment Type
Full Time
