Senior Manager, Global Labeling Compliance & Connectivity
Senior Manager, Global Labeling Compliance & Connectivity

Senior Manager, Global Labeling Compliance & Connectivity

Full-Time 48000 - 72000 £ / year (est.) Home office (partial)
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BeiGene

At a Glance

  • Tasks: Lead global labeling compliance projects and enhance efficiency in the labeling process.
  • Company: BeOne, a biopharmaceutical company dedicated to innovative cancer therapies.
  • Benefits: Competitive salary, professional development, and opportunities for growth in a dynamic environment.
  • Why this job: Join a passionate team fighting cancer and make a real impact in healthcare.
  • Qualifications: 7+ years in pharmaceutical labeling and strong project management skills required.
  • Other info: Collaborative culture with opportunities for international travel and cross-functional teamwork.

The predicted salary is between 48000 - 72000 £ per year.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer. BeOne is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer.

This role will support global commercial labeling projects and programs connected to labeling process effectiveness, efficiency and compliance, including external collaboration initiatives (SDEA labeling compliance) and internal collaboration initiatives across the broader BeOne organization. It requires effective cross-functional collaboration, detailed analyses, and understanding of interdependencies to support a wide range of project planning/management and infrastructure/process activities.

Essential Functions of the job:

  • Monitor and update labeling provision of SDEA labeling contracts, including coordinating with legal and country representatives on updates and taking action if non-compliance occurs.
  • Data remediation activities.
  • Records quality events for regulatory labeling team and monitors assigned CAPAs until issue resolution and closure.
  • Drives cross-functional working groups to identify, assess, design and/or implement improvement opportunities to measure and reduce compliance risk and increase efficiency of the end-to-end Labeling process.
  • Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information.
  • Assists with development, revision and maintenance of departmental SOPs, WIs and non-governance documents.
  • Prepares necessary training and communication to relevant stakeholders to ensure proper process execution.
  • Reporting out of or coordinates the timely availability of metrics and KPIs to demonstrate labeling process compliance and efficiency.
  • Serves as strategic regulatory partner and a liaison between the Global Labeling Business Users of the Systems to IT for new or enhanced technical solutions.
  • Experience in systems (e.g., document management systems, labeling systems, etc.) to meet regulatory requirements is a must.
  • Identifies industry trends and evaluates impact on BeOne labeling policies and practices.
  • Supports development of project strategies within teams and the department.
  • On an ad-hoc basis, supports the preparation of labeling deliverables, for submission to Health Authorities, implementation on market, inspection or audit.
  • Communicates with and provides services to a wide range of internal and external contacts.
  • Anticipates and resolves problems, updates supervisor on status of projects.

Experience:

  • 7+ years pharmaceutical or industry related labeling experience, including significant examples of involvement in regulatory labeling updates and/or process.
  • Direct working experience with labeling process, document management, international labeling differences in execution such as translations, readability, harmonization etc.
  • Strong aptitude for authoring documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.
  • Familiarity with Regulatory Information Management systems.
  • Effective communication skills (verbal and written).
  • Ability to work cooperatively with others and provide significant contributions as a member of a team in addition to serving in a leadership capacity.
  • Strong organizational skills.
  • The ability to be flexible and handle multiple tasks well, under pressure while demonstrating strong attention to detail.
  • Proficiency in MS Office and Project Management tools is mandatory.
  • Familiarity of GMP requirements and working in a highly regulated industry.
  • Good understanding of GxP/GMP applications.

Qualifications:

  • Bachelor’s degree in Project Management, Life Sciences, or other related area, with at least 7 years of applicable experience in pharmaceutical or biotechnology/device industry.
  • Preferred Education: Advanced degree.
  • Prior commercial regulatory labeling required. Project management a plus.

Computer Skills:

  • Ability to work in a strong technical environment, MS Office Suite, knowledge of Project Management tools, Labeling implementation and tracking systems, Document Management Systems, Packaging and Artwork Management Systems, Veeva Vault, Change Management Systems, SharePoint and other technical applications used in the regulatory environment.

Travel: Infrequent; national travel for team meetings and conferences, infrequent international travel.

Core Competencies, Knowledge & Skill Requirements:

  • Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.
  • Strong planning, organizing, and execution skills.
  • Ability to proactively manage workload and meet deadlines.
  • Ability to provide and apply creative solutions to maintain workflow.
  • Ability to work collaboratively within a global team setting, and with staff of different backgrounds and experience levels, listen to and consider stakeholder feedback.
  • Logical problem-solving skills, looks beyond immediate problems to consider root causes and addresses them.
  • Excellent verbal and written skills with great attention to detail.
  • Possess a high degree of personal responsibility, proactivity and agility.

Communication & Interpersonal Skills:

  • Fosters open communication.
  • Listens and facilitates discussion.
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
  • Proven ability to build trust and respect within the organization.
  • Ability to prioritize and handle multiple projects simultaneously.
  • Interacts with internal stakeholders and cross-functional team members, as required.

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

Senior Manager, Global Labeling Compliance & Connectivity employer: BeiGene

BeOne is an exceptional employer that fosters a collaborative and innovative work culture, dedicated to the fight against cancer. With a strong emphasis on employee growth, we offer unique opportunities for professional development in a dynamic global environment, ensuring that our team members are equipped with the skills and knowledge to excel in their roles. Our commitment to excellence and patient-centric values creates a meaningful workplace where every contribution makes a difference.
BeiGene

Contact Detail:

BeiGene Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Manager, Global Labeling Compliance & Connectivity

✨Tip Number 1

Network like a pro! Reach out to your connections in the biopharmaceutical industry, especially those who work at BeOne or similar companies. A friendly chat can lead to insider info about job openings and even referrals.

✨Tip Number 2

Prepare for interviews by researching BeOne's recent projects and initiatives. Show that you’re not just interested in the role but also passionate about their mission to fight cancer. Tailor your answers to reflect how your experience aligns with their goals.

✨Tip Number 3

Practice your problem-solving skills! Be ready to discuss specific examples of how you've tackled compliance issues or improved processes in your previous roles. This will demonstrate your analytical thinking and ability to drive results.

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the BeOne team and contributing to their mission.

We think you need these skills to ace Senior Manager, Global Labeling Compliance & Connectivity

Regulatory Labeling Experience
Project Management
Cross-Functional Collaboration
Data Analysis
Problem-Solving Skills
Attention to Detail
SOP Development
Document Management Systems
Communication Skills
GMP Knowledge
Change Control Management
Analytical Thinking
Technical Aptitude
Organisational Skills
Stakeholder Engagement

Some tips for your application 🫡

Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in regulatory labeling and compliance. We want to see how your background aligns with our mission at BeOne, so don’t hold back on showcasing your passion for fighting cancer!

Showcase Your Skills: Emphasise your strong organisational skills and attention to detail in your application. Mention specific examples of how you've successfully managed projects or improved processes in the past, as this will resonate well with us at BeOne.

Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon where possible. We appreciate candidates who can communicate effectively, especially in a highly regulated environment like ours.

Apply Through Our Website: Don’t forget to submit your application through our official website! This ensures that your application gets to the right people and helps us keep track of all candidates efficiently. We can’t wait to hear from you!

How to prepare for a job interview at BeiGene

✨Know Your Stuff

Make sure you brush up on your knowledge of regulatory labeling processes and compliance. Be prepared to discuss specific examples from your past experience that demonstrate your understanding of the complexities involved in global labeling projects.

✨Show Your Collaborative Spirit

Since this role requires effective cross-functional collaboration, think of instances where you've successfully worked with diverse teams. Be ready to share how you foster teamwork and communicate openly to achieve common goals.

✨Demonstrate Problem-Solving Skills

Prepare to discuss challenges you've faced in previous roles and how you approached solving them. Highlight your analytical thinking and ability to look beyond immediate issues to address root causes, as this is crucial for improving compliance and efficiency.

✨Be Proactive and Detail-Oriented

Emphasise your organisational skills and ability to manage multiple tasks under pressure. Share examples of how you've proactively managed workloads and ensured attention to detail in your work, especially in a highly regulated environment.

Senior Manager, Global Labeling Compliance & Connectivity
BeiGene
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