Sr. Labeling Scientist (Senior Manager, US) Position Available In Wake, North Carolina

Make your mark for patients We are seeking an experienced US Senior Labeling Scientist (Senior Manager) to play a pivotal role in shaping the strategic direction of product labeling, working closely with cross-functional teams to ensure that labeling aligns with both regulatory requirements and business goals. In collaboration with the Regulatory Advertising and Promotion (A&P) representative, this role is instrumental in the development and optimization of key regulatory documents such as the TPVP, TCLP, and CCDS. By providing strategic input, the Senior Labeling Scientist (Senior Manager) ensures that local labeling not only meets FDA guidelines but also supports competitive positioning, market access, and effective product promotion in the US market.

About the role:

Strategic Labeling Development:

Lead the development and maintenance of US product labeling, ensuring it aligns with the CCDS and adheres to FDA regulations and guidelines.

Cross-Functional Collaboration:

Serve as a strategic leader in the US Labeling Review Committee (LRC), facilitating productive discussions to gain alignment across functions and ensure that all stakeholders are informed and engaged in the labeling process.

Labeling Artwork Strategy:

Lead the development of product labeling artwork by providing clear, strategic regulatory input on content, layout, and visual elements. Ensure that the artwork complies with FDA regulations and enhances the marketability of the product while maintaining regulatory integrity.

Regulatory Leadership and Guidance:

Act as the go-to expert for regulatory labeling matters, providing guidance and oversight to the US Labeling Scientist and other teams as needed. Who you’ll work with: The Senior Labeling Scientist (Senior Manager) will partner with the US Regulatory Science Lead and cross-functional subject matter experts to drive consistency and regulatory compliance across product labeling. Collaborate closely with the Regulatory A&P representative to ensure that labeling is optimized to support both regulatory compliance and marketing objectives. Additionally, the Senior Labeling Scientist (Senior Manager) ensures that the US Advertising and Promotion representative is actively involved in labeling development discussions, providing key insights into how the labeling may impact promotional strategies and ensuring alignment with product messaging. What you’ll do: US Regulatory expert regarding requirements for US regulation of drug labeling. Engage in TPVP, TCLP, and CCDS discussions to support development of competitive US labeling. Lead development and maintenance of US product labeling consistent with the CCDS and FDA regulations/guidelines Lead Labeling Review Committee meetings to gain labeling alignment among cross-functional subject matter experts. Provide competitive labeling landscape for reference in labeling development. Participate in process improvements to enhance efficiency of labeling development and maintenance. Interested? For this position you’ll need the following education, experience, and skills: Bachelor’s degree in health sciences, business or related field is required. Minimum of 7 years’ experience in Regulatory Affairs and 5 years’ experience in Regulatory labeling strategy. In addition, a minimum of 2 years of Regulatory advertising and promotion review experience. Expert knowledge of US laws, regulations, and guidances related to pharmaceutical product labeling development. Demonstrated examples of strong leadership, communication, interpersonal skills, and an ability to strategically both assess and navigate risk. Well established ability to work collaboratively and influence cross-functional teams, manage multiple projects and prioritize competing deadlines. Proven track record of thinking strategically and creatively to regulatory challenges. Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. UCB is an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race/ethnicity, color, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Requisition ID:

89251

Recruiter:

Chris Venegas Hiring Manager:

Jennifer Brown Talent Partner:

Bianca Hinshaw Job Level:

MM II Please consult HRAnswers for more information on job levels.