We all share one big ambition. What’s yours?
Everyone who works at UCB holds the same ambition – to transform the lives of people living with severe diseases. Of course we have otherassociated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals. That’s why we ensure every UCB colleague has the tools and environment to engage effectively in the work we do. Wherever in the world we’re based, and whatever role we play, we believe each of us can have an impact across our organization.
To help us meet our ambitions and provide the best solutions to patients, UCB is currently seeking a talented individual as a Regulatory Labeling, Advertising and Promotion Scientist, US based at our US Headquarters in suburban Atlanta, Georgia.
We are seeking a candidate with a strong background/experience in writing within US guidelines (e.g.: Type B or Type C meeting request and briefing documents).
- Provide oversight of the US labeling process, including generation of new labeling and changes to existing labeling, and submission of labeling information to the FDA, and for the regulatory review and submission of advertising and promotional materials for all UCB products marketed in the US.
Labeling Responsibilities for Assigned Products
• Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to others as needed.
• Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
• Provide Regulatory guidance on clinical trial design in product development project teams to enable promotion of clinical trial data and desired product claims .
• Direct the production of new labeling text in conjunction with Regulatory Science Leads and Scientists. Ensure that new labeling text meets regulatory labeling requirements.
• Interface with the Global Labeling Function to ensure consistency of labeling processes and local compliance with CCDS.
• Direct submission of labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
• Oversight of Labeling Review Committee activities.
• Serve as US Labeling expert in Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.
• Serve as US Labeling expert in Global Labeling Committee meetings and advises on FDA requirements and historical FDA labeling negotiations to support GLC discussions as needed.
Promotional Material/External Communications Responsibilities
• Develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape. Communicate FDA requirements to other UCB departments involved in the preparation or review of external communication materials.
• Collaborates with originators and cross functional team in the development of new promotional initiatives/programs and reviews supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Negotiates promotional regulatory position within cross-functional team.
• Directs coordination of complex OPDP submissions in collaboration with Regulatory Labeling, Advertising and Promotion Manager, US
• Direct the regulatory review of non-promotional scientific information, and external communication materials, including media information and provides proactive feedback.
• Provide leadership and guidance to labeling/promotion managers.
• Interact with senior management, external departments and regulatory authorities as needed.
• Participate in forecasting and planning activities for resources for the US Regulatory Affairs group for the future needs for Regulatory Affairs.
Minimum requirements – Education and Experience:
- Bachelor’s degree in Science or related discipline; Master’s degreepreferred
- At least 8years of relevant experience in the pharmaceutical industry with preferably 6 years in Regulatory Affairs and specific experience in US labeling and promotion
- Extended knowledge of US labeling and promotion regulations and guidance.
- Extended knowledge of science and data of assigned products and how that translates into labeling language.
- Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.
- Experience of product launch preferred.
- Experience with device labeling preferred.
- Expanded understanding of BioPharma business.
- Demonstrated expertise intechnologysystems utilized for electronic documentation, including, but not limited to: Microsoft Office, Adobe Acrobat and Mikado.
Skills and Capabilities:
• Integrity: overriding commitment to integrity and high standards in self and others.
• Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.
• Strategic orientation: ability to link visions and daily work
• Communication: ability and intend to effectively explain, describe or convey information to a variety of audiences. Specifically, interacts effectively as member of the Regulatory sub-team, communicates effectively strategies to the Global Labeling Committee and collaborates with business partners, including affiliates and third parties.
• Develops others: involved in a genuine intent to foster development of others; mentoring
• Flexibility/adaptability: ability to adapt to, and work effectively within a variety of situations and with various individuals or groups.
• Relationship building, team work and cooperation: builds or maintains friendly relationship with people and demonstrates desire to work
• Analytical Thinking: understand a situation by breaking it apart into small pieces, or tracing the implications of a situation in a step-by-step way. Systematically organizing the parts of a problem.