Regulatory Operations Manager
Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.
We are located in the San Francisco bay area, in the heart of the world’s largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.
Arcus has an exciting opportunity for an Manager of Regulatory Operations who will be responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations function at Arcus and help to found an approach for regulatory submissions.
This position will provide support to the Regulatory Affairs organization with an immediate focus on support of submissions in the US. This person will collaborate closely with other Regulatory Operations personnel to establish the Regulatory Operations department as a whole. This person will help establish and create the Publishing, Document Processing, Archiving, and Regulatory Systems Functions.
The Regulatory Operations Manager supports the regulatory submission process by tracking, formatting and publishing submission documents for paper and electronic format in compliance to internal and external specifications, formatting MS Word documents, and providing system support for the Veeva Vault RIM platform. This position is also responsible for coordinating the regulatory archive with Veeva Vault RIM.
Essential Duties & Responsibilities:
- Publishing & Document Processing
- Format MS Word and Adobe Acrobat files to a state of submission-readiness
- Tracks and compiles submission component documents from paper and/or electronic sources; edits, formats, assembles, and publishes submission documents in accordance with established timelines.
- Ensures completion of high-quality submissions in electronic (eCTD) and paper format for compliance with all applicable regulations, guidance’s, and Regulatory Operations document specifications.
- Assists submission authors and regulatory liaisons in the planning and preparation of regulatory submissions; when appropriate, composes regulatory forms, correspondence, and text.
- Assists in the development of and implements documentation standards, templates, and procedures related to the formatting, publishing, and archiving of both electronic (eCTD) and paper submissions.
- Archiving and Regulatory Information Management
- Manage and maintain correspondence and other records in Vault RIM
- Archives/retrieves archived regulatory documents (both paper and electronic) as necessary.
- Ensure that all documents are maintained in Veeva Vault RIM and are organized and identified so that they can be easily retrieved.
- Ensure that records are maintained in accordance with current procedures and the Records Retention Schedules.
- Ensures that all submission planning and tracking is done per procedures and is consistent with Arcus’s RIM vocabularies
- Provides training and support for eCTD Viewing Tools such as Veeva Vault and Rosetta Phoenix eCTD Viewer
- Veeva Vault RIM Platform System Support
- Provides Business subject matter expert support for the Veeva Vault RIM platform including training, customer education and troubleshooting issues.
- Maintain up-to-date knowledge of global standards and procedures for regulatory submissions, [including eCTD, IDMP] publishing standards and analyzes new and revised guidance providing input to new requirements
- Monitors the Vault RIM support Inbox and helps with access issues, training, questions, etc. to support Vault RIM
- Participated in the Vault RIM User Forum, Vault RIM Validation efforts, and other tasks related to the maintenance and updating of Veeva Vault RIM.
Qualifications (including knowledge & skills):
Knowledge, skills and experience:
- Successful candidates will have significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
- Working knowledge of business software, including: MS Word, Excel, PowerPoint, Teams, OneDrive, Project, Adobe Acrobat and Outlook.
- Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required
- Strategic thinking is required, with a focus on process improvement and optimization.
- Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
- Candidates will demonstrate an ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
- Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
- Ability to communicate technical issues to a non-technical audience.
- Must have excellent verbal, written, extensive organizational and time management skills and a strong attention to detail.
- Experience working in and directing cross-functional teams is highly preferred.
- Familiarity with pharmaceutical development and global Regulatory submissions is required.
- 5+ years of relevant experience and a BA or BS or 2+years with Master or above