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.
BeiGene is seeking an experienced and energetic person to help
manage the global labeling governance process for both products in
development and marketed products. He/she will be responsible for
the creation and management of Core Labeling documents (company
core data sheets, core patient information leaflets), as well as
labeling processes development/improvement. The incumbent will
provide regulatory support for designated projects ensuring that
the latest requirements and standards are met. Externally, the
individual may interface with outside regulatory agencies and
business partners. He/she will also support/lead development and
implementation of department policies and SOPs.
Essential Functions of the job:
- Use knowledge of US, EU and ICH regulatory requirements to plan
and manage assigned projects to support corporate goals.
- Assist/lead the preparation and revision of Core Labeling
documents (CCDS, CPIL).
- Assist the global labeling governance process, including
drafting of SOPs and Work Instructions
- Assist/lead the coordination of the Labeling Committee process,
documenting and tracking decisions and actions, and maintaining
- Assist/manage the entire labeling process and management of
revisions, including assigning/tracking projects, workflow
execution, and issue resolution.
- Assist in the development and maintenance of the end-to-end
(E2E) labeling process.
- Build partnerships with key stakeholders from other functions
to ensure that strategic business goals are met through the sharing
of knowledge and expertise.
- Maintain awareness of global regulatory environment and assess
impact of changes on business and product labeling activities.
Facilitate policy and development of standard interpretation with
- Assist with the development and implementation of regulatory
- Other duties as assigned.
- Understanding of product labeling and regulatory requirements
in the pharmaceutical industry and ability to manage global core
- Strong business acumen and ability to make sound decisions that
contribute positively to the business.
- Proven ability to deliver on goals within a cross-functional
team/partnership environment with a high level of
- Excellent oral and written communication skills are a must, as
are superior planning skills.
- The candidate should be detailed-oriented, a self-starter, and
be comfortable with broad responsibilities in an entrepreneurial,
- Regulatory Affairs Labeling experience is highly desired.
Education Required: Bachelor's degree (BS/BSc or BA), preferably
in a scientific or health-related discipline, with at least 3 years
Ethics - Treats people with respect; Inspires the trust of
others; Works with integrity and ethically; Upholds organizational
Planning/Organizing - Prioritizes and plans work activities;
Uses time efficiently. Completes administrative tasks correctly and
on time. Follows instructions and responds to management
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
Technical Skills - Assesses own strengths and development areas;
Pursues training and opportunities for growth; Strives to
continuously build knowledge and skills; Shares expertise with
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
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
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.
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,
non-disqualifying physical or mental disability, national origin,
veteran status or any other basis covered by appropriate law. All
employment is decided on the basis of qualifications, merit, and