ASSOCIATE MANAGER, REGULATORY TECHNOLOGY

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.

 

 

The Associate Manager, Regulatory Technology, will be responsible for providing post-production support, training, and systems maintenance/upgrade support, for all Regulatory Technology & Information Management systems supported by the Global Regulatory Operations team.

 

System and Training Support will be provided to the Global Regulatory Affairs organization. This role will collaborate closely with the project teams, IT partners and business stakeholders to ensure systems and processes are compliant with ISO, ICH, FDA, and other regional regulatory requirements.

 

Essential Functions of the job:

• Work across geographic regions to ensure Global Regulatory Operations (GRO) systems support and functional needs are met
• Provide direct support for GRO Systems change control process 
• Serve as primary contact and local expert for the GRO systems Change Control Board (CCB), as part of the Change Management framework
• Participate in Regulatory system implementations and upgrades
• Provide support for system related documentation and training materials
• Assist and/or provide system training and demos to users
• Maintain up-to-date knowledge of global standards and procedures for regulatory submissions publishing processes
• Provide global and local support for regulatory systems and tools
• Provide first-level of support and liaison between IT and business
• Provide SME-level assistance for the resolution of support tickets
• Assist with the provisioning and access control of all regulatory systems
• Work across geographic regions to ensure support and functional needs are satisfied
• Track system issues and defects and mitigate
• Partner with IT and external vendors in the oversight of system issues
• Collect and analyze feedback from system users
• Interacts frequently with other functional areas. Maintains constructive, positive interactions and a trustful relationship with colleagues

 

 

Qualifications:   

• Bachelors degree or equivalent experience required
• 4+ years in the bio-pharmaceutical industry supporting regulated systems is required
• Working knowledge of regulations, processes and industry standards that govern regulated systems, records retention, and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance
• Working knowledge of drug development and submission requirements
• Experience in managing day-to-day administration of regulated systems
• Excellent written, verbal, and interpersonal communication skills 
• Team player capable of managing multiple projects and tight timelines in a team environment 
• Excellent organizational and multi-tasking skills 
• Ability to problem solve and troubleshoot under pressure 
• Ability to work independently under general supervision and adapt to changing priorities 

 

Computer Skills:   

• Proficient in Document management and RIMS (Veeva RIM Suite Preferred)
• Microsoft Office and Adobe systems knowledge
• Collaboration Tools (SharePoint, etc.)
• eCTD Publishing Tools (InSight Publisher/Viewer)
• Off-the-shelf and plug-in software (StartingPoint Templates, DXC Toolbox)

 

Travel:  <;20%

 

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

 

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time.  Follows instructions and responds to management direction.

 

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.  Writes clearly and informatively.  Able to read and interpret written information.

 

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.  Contributes to building a positive team spirit; Shares expertise with others.

 

Adaptability – Able to adapt to changes in the work environment.  Manages competing demands.  Changes approach or method to best fit the situation.  Able to deal with frequent change, delays, or unexpected events.

 

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

 

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

 

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

 

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

 

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

 

Project Management - Communicates changes and progress; Completes projects on time and budget.

 

 

 

 

 

 

 

 

Salary Range: $97,300.00 - $132,300.00 annually

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.