Director, Regulatory Affairs Labeling
Posted on Apr 5, 2021 by BeiGene, Ltd.
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on global labeling strategies for both products in development and marketed products. This individual will manage regulatory labeling through all phases of development and post-approval. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management to plan, evaluate and recommend regulatory labeling strategy. Externally, the individual will interface with outside regulatory agencies and business partners regarding labeling strategies. He/she will also support/lead development and implementation of department policies.
Essential Functions of the job:
Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory labeling strategies, requirements, and associated risk assessments.
Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
Manages the preparation and revision of regional labeling and global company core data sheets.
Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to labeling including resolution of key regulatory issues and labeling changes.
Maintains 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 stake holders.
Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure.
Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
Manages critical issues, taking leadership for the regulatory contribution
Responsible for assisting with the development and implementation of regulatory processes
Recruits, develops, manages and mentors regulatory professionals and helps create a goal-oriented culture.
Computer Skills: Working knowledge of Microsoft Office Suite applications and document management systems.
Bachelor's degree (BS/BSc or BA), preferably in a scientific or health-related discipline, with minimum of 10 years in the biotechnology or pharmaceutical industry and a minimum 5 years in a Regulatory capacity with a broad background. Preferred candidates will have experience working as a lead in Regulatory Affairs Labeling across two or more major geographic areas and prior experience with both small molecules and biologics.
Thorough understanding of product labeling regulatory requirements in the pharmaceutical industry and healthcare environment including policy trends.
Extensive regulatory experience leading and managing the development and maintenance of product labeling, and associated review processes.
Strong business acumen and ability to make sound decisions that contribute positively to the business
Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
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.
Travel: ~10 - 20% as required
This role will lead a future team within the Regulatory Labeling group.
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.
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 everyones 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.