Senior Associate, Submission Operations

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 Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format to global health authorities. Strong experience with submitting to the EU, US, Canada and Asia Pacific countries in eCTD, NeeS and paper format.

Essential Functions of the job:

• Act as lead publisher when required, for major applications.  Provide leadership to plan resources, deliver on strict timelines, track and report submission progress internally and externally, organize appropriate levels of technical support, and actively resolve technical issues.

• Responsible for both report level publishing and submission level compilation for global major applications and lifecycle submissions (routine).  This includes all document management tasks, creation and qc of all navigation and technical acceptance (e.g. hyperlinking, bookmarking, validation) to ensure submission compliance for Health Authority (HA) acceptance.

• Support Regulatory Affairs to deliver high quality and consistent maintenance health authority submissions, through the provision of strategic insight and broad operational level knowledge for those submission types.

• Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation.

• Represent the Regulatory Operations team on both submission (e.g. Global Filing team) and Regulatory projects teams to provide status and input related to key deliverables (e.g. impact to submission timelines).

• Review and contribute to the implementation of standards, templates, and procedures related to regulatory documents, recommend associated process improvements. 

• Act as mentor to junior resources.

• Assist in the evaluation, implementation or upgrade of software, e.g., publishing, validation, viewer or electronic document management systems.

• Strong working knowledge of submission requirements and guidelines for all submission types, both paper and electronic and strong experience in the regulatory submission process.

• Familiarity with formatting of regulatory submission documents ensuring that documentation meets external and internal company submission-ready standards.

• Attention to detail, organized and ability to support multiple simultaneous projects.

• Ability to work under challenging deadlines with high quality and consistency.

• Ability to work flexible business hours as required to support global submissions within a global Regulatory Operations team. Ability to work beyond core business hours as required. 

Supervisory Responsibilities:  

• None

Technical Skills:  

• Experience using eCTD compliant publishing system.

• Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness.

• Knowledge of MS Word Templates, their function and use.

• Working knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks.

• Experience with document management and Regulatory Information Management Systems (RIM).

• Veeva RIM Required, Veeva Publishing preferred.

Travel: 

Travel as required (Approximately 10%)

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

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.