Senior Manager, Submission Operations Management

Job Description :

General Description :

The Senior Manager of Submissions Operations (JP) will help establish the Submission Operations Team in Japan. This role supports Regulatory Affairs personnel in the coordination, preparation, and submission of all Japanese CTNs / NDAs and lifecycle management of these submissions in electronic format to global Health Authorities, with immediate focus on supporting submissions in Japan, but also provide support as needed for China, APAC, EMEA, and NALA regions. This role will also work cross-functionally and closely with GTS and Global Regulatory Operations Strategy & Innovation teams including but not limited to Regulatory Technology & Regulatory Information Management group to provide post-production support and training for colleagues in Japan, as needed.

Essential Functions of the job :

• Maintain working knowledge of regulatory guidance and regulations of ICH and regional / country Health Authorities, with a focus in Japan eCTD guidance.
• Lead and promote initiatives in moving the company forward with the implementation of new systems, processes and services.
• Assist and / or provide training to others on software tools and educate authors on publishing policies and procedures.
• Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions.
• Lead strategic processes and provide strategic value to the overall positioning of the department with BeiGene
• Allocate project resources within the company and with offsite vendors to ensure adequate resourcing for BeiGene regulatory dossiers
• Responsible for forward planning of publishing resources with an awareness of long-term filing plans and advises senior management of resource implications.
• Interacts frequently with other functional areas. Maintains constructive and positive interactions with colleagues.
• Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects.
• Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management.
• Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts.
• Represent Regulatory Operations by taking the lead in submission planning meetings to help become familiar with the submission priorities.
• Lead the development and management of projects as applicable in support of the Regulatory Operations department.
• Manage / mentor and develop junior members of staff, as needed

Supervisory Responsibilities :

Qualification Required :

Education Required :

BA / BS degree in Life Sciences with 10+ years of experience or MS with 8+ years of experience in Regulatory Operations within the biotechnology or pharmaceutical industry. Proficient in written and spoken Japanese with experience in managing Japan submissions

Qualifications :

Computer Skills :

Other Qualifications : Ability to work beyond core business hours as required.

Travel : Travel as required (Approximately 10%)

What We Offer To Our Valued Employees

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job