Browse New and Exciting Opportunities
So sorry, this position is no longer available.
Please go ahead and submit your application. We may have other positions that would be the perfect fit for you.
Alternatively, you may want to apply to one of the following related jobs:
The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
true
Regulatory Operations and Submissions Manager
Remote, NY US
Posted: 08/19/2024
2024-08-19
2024-09-27
Employment Type:
Direct Hire
Job Category: Regulatory
Job Number: 3872
Job Description
The Regulatory Operations and Submissions Manager manages complex submission projects and related processes. Working cross-functionally to maintain processes and procedures related to regulatory submissions, the individual will assist in oversight of the integrity of the regulatory information management (RIM) system.
Responsibilities:
Requirements/Qualifications:
Responsibilities:
- Act as a key Regulatory Operations representative for cross-functional working teams for matters related to electronic document management and regulatory submissions.
- Manage the development and maintenance of a submission content plan, which includes a detailed list of all submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC
- Act as Business Administrator for the day-to-day administration of Veeva Vault RIM
- Assist change control efforts for configuration change requests on lifecycles, workflows, security settings, objects, document types/subtypes, etc.
- Manage changes to system dictionaries, controlled vocabulary lists, templates, submission package (binder) structures, picklist values, document classifications, and other incidental changes in the system.
- Assist in development and maintenance of training program
- Act as a point of contact for users who have questions on the system
- Assist with internal and external audits and inspection readiness activities.
- Provides support in on-boarding and training new staff and provide ongoing guidance for system and processes.
- Leads and participates in the development of optimal business processes (internal guides/work instructions, SOPs, etc.) and practices within the department to ensure high levels of support and to achieve high quality submissions and cost efficiency.
- Responsible for independently managing and executing own projects and escalates issues or needs for support/resources to management as needed
- Performs various document management assignments, including file transfer, migration, storage, tracking, and archival of regulatory submission and other functional area documentation.
- Manage/provide guidance and operational oversight to ensure timely, high quality regulatory submissions. Participates in the development and execution of project plans.
- Independently manage outsourced e-Publishing Vendor
- Develop and implement publishing standards and processes for cross-functional regulatory submissions
- Establish standard and best practices for day-to-day operations related to the management of documents related to Regulatory Submissions Operations
- Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory submissions and keeps abreast of changes to regulations/guidances
- Has solid technical and analytical skills and is able to recommend changes to or troubleshoot systems
- Gather metrics on specific tasks and technical aspects for management updates
- May supervise other Regulatory Operations staff
Requirements/Qualifications:
- Bachelor’s degree and 7+ years of experience working in biotech/pharmaceutical industry
- 6 years of experience working in a regulatory, quality or compliance function with at least 4 years of regulatory operations experience in biotech/pharma industry.
- Experience required in publishing activities and pre-publishing activities as well as compilation of eCTD submissions.
- Publishing both US and ex-US submissions.
- Viewed internally as a technical expert in the field of Regulatory Operations
- Possesses an advanced, thorough understanding of global regulatory agencies’ submission processes, ICH eCTD and regional specifications and information systems used in regulatory publishing/submissions activities
- Experience with Veeva Vault RIM
- Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and eCTD publishing tools required.
- Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail including proofreading required.
- Ability to multi-task, pay close attention to detail, and follow projects through to completion.
- Experience developing business processes, Standard Operation Procedures, and Work Instructions preferred
- Experience developing and giving trainings and guidance to various functions preferred.
- Ability to work in a cross-functional team environment with changing timelines and priorities required.
- Familiarity with competitive intelligence, regulatory standards, and information governance skills preferred.