Job Description

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 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 format to Health Authorities in the EMEA region. Additional experience with submitting applications/dossiers to US, Canada, and Asia Pacific countries/regions in eCTD, NeeS and paper format is also preferred.
This position will actively participate in the development of streamlined submission processes, internal quality checks, and metrics reporting based on industry best practices. A key success factor is the ability to develop and maintain cross functional relationships to enable high quality output, timely and compliant submissions to Health Authorities within EMEA.
This position will oversee the daily activities (e.g. document processes, submission publishing) of the EMEA Publishing and DFR (Document Formatting Review) function, as applicable.
Essential Functions of the job:Extensive experience with regulatory submission processes, documents, and requirements, such as INDs, clinical trial applications, Therapeutic Biologics Applications (BLA). Strong project/submission management skills to drive the development and implementation of robust submission publishing activities associated with generating electronic/paper submissions. This includes working with internal staff and external vendors to produce regional compliant dossiers. Solid knowledge about Veeva Vault RIM, knowledgeable about Veeva Publishing beneficial Profound knowledge about various gateways/portals e.g. EMA Gateway, Swissmedic Portal, MHRA Portal, ESG Portal, SAPHRA Portal Work with peers to drive the establishment of global submission processes (e.g. submission checklists, internal authoring standards, publishing timelines, and supporting tools) while providing strategic value to the overall positioning of the function. Allocate publishing/technical editing resources; ensure compliance with global regulatory submission requirements and timeliness of submitting regional dossiers. Responsible for resource allocation based on short and long-term filing plans and advises management of resource implications. Communicate/report on "on-going" project status to management; sets expectations where necessary and takes decisions regarding issue resolution. Support Regulatory Affairs Strategists with managing submission documentation, and internal review processes for regulatory dossiers. Excellent interpersonal skills with the ability to build strong relationships across multiple functions and organizations. Ability to work independently and with the flexibility to handle workflow in a fast-paced environment. Ability to interpret, communicate, and present regulatory information in a clear and concise manner. Excellent written/verbal communication skills Manage projects with minimal supervision Proficiency with MS-Office Suite and Adobe Acrobat Pro and Adobe plugins Attention to detail and strong organizational skills Self-starter, able to work independently and flexibility to adapt quickly to changing requirements Experience with SPOR and/or CTIS would be an advantage Demonstrated ability to adjust priorities with strict deadlines to successfully complete multiple tasks

Education Required:Bachelor's of Science degree in a relevant scientific or life sciences discipline required (or equivalent in experience) 3-5 years of experience in working in a biotechnology or pharmaceutical Regulatory Affairs/Operations, Submission Support function. Proven success in compiling and filing regulatory submissions and Marketing Authorizations end to end.

Supervisory Responsibilities:May have direct report

Computer Skills:Microsoft Office 365, especially MS Teams and Adobe systems Document Management or Authoring Tools (e.g. Documentum, CARA, Veeva Vault, etc.) Regulatory information management systems (e.g. Liquent InSight, IQVIA, Veeva Vault, etc.) Collaboration Tools (e.g. SharePoint, etc.) Labeling and eCTD Publishing Tools (e.g. Calyx RIM, DocuBridge, Veeva Publishing) Off-the-shelf and plug-in software (StartingPoint Templates, CSC Toolbox) Experience working across two or more major geographic areas.

Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.