Regulatory Affairs Labeling Manager

Company: BeiGene, Ltd. APAC
Location: Fulton
Posted on: June 12, 2021

Job Description:

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:

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 archives.
• 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 internal stakeholders.
• Assist with the development and implementation of regulatory processes.
• Other duties as assigned.

Qualifications:

• Understanding of product labeling and regulatory requirements in the pharmaceutical industry and ability to manage global core labeling processes.
• 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 professionalism.
• 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, fast-paced environment.
• 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 (Manager).

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.

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 business need.

Keywords: BeiGene, Ltd. APAC, Columbia , Regulatory Affairs Labeling Manager, Other , Fulton, Missouri