Manager, Submissions Operations Management - Emea

BeiGene; Vigo; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading biotechnology company is seeking a Regulatory Submissions Manager to support EMEA operations. Candidates should have a strong background in regulatory submission processes, project management skills, and a Bachelor's degree in a relevant field. You will be responsible for managing the preparation and submission of critical documents to health authorities, ensuring compliance with industry standards.

Formación

• 3-5 years' experience in biotechnology or pharmaceutical Regulatory Affairs.
• Proven success in end-to-end regulatory submissions.
• Strong project and submission management skills.

Responsabilidades

• Manage preparation and submission of CTAs and MAAs.
• Develop and implement streamlined submission processes.
• Oversee document processes and submission publishing.

Conocimientos

Regulatory submission processes

Submission management

Project management

Attention to detail

Analytical Thinking

Educación

Bachelor’s degree in a relevant scientific or life sciences discipline

Herramientas

MS Office 365

Adobe Acrobat Pro

Veeva Vault RIM

Calyx RIM

DocuBridge

Descripción del empleo

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 supports 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 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. Building and maintaining cross-functional relationships to ensure high-quality, timely, and compliant submissions within EMEA is key.

The position oversees daily activities such as document processes and submission publishing within the EMEA Publishing and DFR (Document Formatting Review) functions, as applicable.

Essential Functions of the job :

• Extensive experience with regulatory submission processes, documents, and requirements (e.g., INDs, clinical trial applications, BLA).
• Strong project and submission management skills to develop and implement robust submission publishing activities, working with internal teams and external vendors to produce compliant dossiers.
• Knowledge of Veeva Vault RIM and Veeva Publishing is beneficial.
• Familiarity with gateways/portals such as EMA Gateway, Swissmedic Portal, MHRA Portal, ESG Portal, SAPHRA Portal.
• Drive the establishment of global submission processes, including checklists, standards, timelines, and tools, providing strategic value.
• Allocate publishing and technical editing resources, ensuring compliance and timeliness.
• Manage resource allocation based on filing plans and advise management on implications.
• 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 Pro, and related plugins.
• Attention to detail, organizational skills, and adaptability to changing requirements.
• Experience with SPOR and/or CTIS is advantageous.
• Ability to prioritize and meet strict deadlines.

Education Required :

• 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, Submission Support.
• Proven success in end-to-end regulatory submissions and Marketing Authorizations.

Supervisory Responsibilities :

• Potential for direct report.

Computer Skills :

• Microsoft Office 365, MS Teams, Adobe systems.
• Labeling and eCTD Publishing Tools (e.g., Calyx RIM, DocuBridge, Veeva Publishing).
• Additional software tools like StartingPoint Templates, CSC Toolbox.
• Experience working across multiple geographic areas.

Our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit are reflected in our competencies, helping us deliver more affordable medicines worldwide.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Acts Inclusively
• Demonstrates Initiative
• Results-Oriented
• Analytical Thinking / Data Analysis
• Communicates with Clarity

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