BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
This position is responsible for supporting the EMEA (Europe, Middle East, Africa) regional lead of SOM by managing the preparation and submission of all CTAs / MAAs and lifecycle management of these submissions in both paper and electronic formats to Health Authorities in the EMEA region. Experience with submitting applications/dossiers to US, Canada, and Asia Pacific countries/regions in eCTD, NeeS, and paper formats is preferred.
This role involves developing streamlined submission processes, conducting internal quality checks, and reporting metrics based on industry best practices. A key success factor is maintaining cross-functional relationships to ensure high-quality, timely, and compliant submissions to Health Authorities within EMEA.
The position oversees the daily activities of the EMEA Publishing and DFR (Document Formatting Review) functions, including document processes and submission publishing.
Essential Functions:
* Extensive experience with regulatory submission processes, documents, and requirements such as INDs, clinical trial applications, and BLA.
* Strong project and submission management skills to develop and implement robust submission publishing activities, working with internal teams and external vendors to produce regional compliant dossiers.
* Knowledge of Veeva Vault RIM and Veeva Publishing is beneficial.
* Familiarity with portals such as EMA Gateway, Swissmedic Portal, MHRA Portal, ESG Portal, and SAPHRA Portal.
* Drive the establishment of global submission processes, including checklists, standards, timelines, and tools, adding strategic value.
* Allocate resources for publishing and technical editing, ensuring compliance and timeliness of submissions.
* Manage resource planning based on filing plans and advise management accordingly.
* Report project status to management, set expectations, and resolve issues.
* Support Regulatory Affairs with managing submission documentation and review processes.
* Build strong relationships across functions and organizations.
* Work independently in a fast-paced environment, interpreting and presenting regulatory information clearly.
* Manage projects with minimal supervision.
* Proficiency in MS Office, Adobe Acrobat, and related plugins.
* Attention to detail, organizational skills, and adaptability.
* Experience with SPOR and/or CTIS is advantageous.
* Ability to adjust priorities to meet deadlines.
Education and Experience:
* Bachelor’s degree in a relevant scientific or life sciences discipline or equivalent experience.
* 3-5 years of experience in biotechnology or pharmaceutical Regulatory Affairs/Operations, including end-to-end submission filing.
Supervisory Responsibilities:
* Potential for direct report(s).
Computer Skills:
* MS Office 365, MS Teams, Adobe systems, and eCTD publishing tools like Calyx RIM, DocuBridge, Veeva Publishing.
* Experience with templates and plugins such as StartingPoint and CSC Toolbox.
* Experience working across multiple geographic regions.
We uphold values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, reflected in our competencies such as teamwork, feedback, inclusivity, initiative, results orientation, analytical thinking, and clear communication.
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