Manager, Submission Operations Management

BeiGene 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 person will be responsible for supporting the regional head of Submission Operations Management (SOM) by managing the day-to-day operations of the SOM team. This person will take an active part in continuing to grow the SOM team at BeiGene by recruiting and developing high quality talent and leading the development of robust submission processes based on industry best practices. In this role, this person will serve as the Regulatory Operations representative on Global Submission filings teams providing input and guidance related to submission processes, timelines and training.  A key to success in this role is the ability to develop and maintain cross functional relationships such that this collaboration drives high quality work and timely delivery of filings to global health authorities.
 

Essential Functions of the job:

• Oversee end-to-end dossier execution activities including submission planning (including scheduling and resource allocation), document format review, submission publishing (including QC), submission dispatch and archiving regulatory submissions in both paper and electronic media to global health authorities (e.g. US, EU, CN and APAC).

• Manage internal Submission Operations Management personnel, vendors and consultants.

• Lead the development and implementation of standards for publishing, archiving, metrics and submission process to global health authorities.

• Monitor and assess business trends, pending regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans, and business tools accordingly.

• Ability to determine and assign adequate resources to projects as needed to ensure high quality outputs.

• Collaborate cross functionally within and outside of RA to provide submission operation subject matter expertise.

• Ability to lead and train others on BeiGene tools and processes.

Qualifications:

• Successful candidates will have significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge

• Able to effectively operate both independently and as part of a cross functional team

• Ability to multitask and work under pressure and tight deadlines

• Working knowledge of regulatory guidelines

• Manage complex submission publishing activities associated with generating hard copy and electronic submissions. 

• Responsible for forward planning of Publishing resources and oversight of junior colleagues.  Understands long-term filing plans and advises Regulatory Operations management of resource implications

• Able to present to large groups and executive level meetings as required for communication and transparency. Interface with Regulatory project managers, Regulatory Affairs, and submission subject matter experts (SMEs) to provide support and guidance on submission preparation.

• Able to eloquently describe complex issues and recommend a resolution or workaround to management with appropriate consideration of possible impacts.

Supervisory Responsibilities:  

• Line management function as required but not limited to performance reviews, compensation reviews, 1:1s, interviewing and onboarding.

• Training and mentoring of junior staff

• Manage vendor relationships as required, support issue resolution

Education/Experience:

• BS/BA with 5+ years or relevant experience in regulatory operations.
   

Other Qualifications:  

Ability to work beyond core business hours as required.  

Travel: 

Travel as required (Approximately 10%)

BeiGene 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.

• 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

BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.