Sr. Labeling Strategist (Remote with 20% onsite presence)

UCB • Smyrna, GA

233d • Remote

About The Position

We are seeking an experienced US Senior Labeling Strategist 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 to join our Regulatory Labeling, Advertising and Promotion team located in Atlanta, GA. Our team operates in a hybrid model and would ideally be based out of our US Headquarters in Atlanta, GA, but could also be based out of our Raleigh, NC location. Additionally, this position will be open to remote candidates with a requirement to be onsite 20%. 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 Strategist ensures that local labeling not only meets FDA guidelines but also supports competitive positioning, market access, and effective product promotion in the US market.

Requirements

• Bachelor's degree in health sciences, business or related field is required.
• Minimum of 7 years' experience in Regulatory Affairs.
• 5 years' experience in Regulatory labeling strategy.
• 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.
• Ability to strategically assess and navigate risk.
• Well established ability to work collaboratively and influence cross-functional teams.
• Proven track record of thinking strategically and creatively to regulatory challenges.

Responsibilities

• Lead the development and maintenance of US product labeling, ensuring it aligns with the CCDS and adheres to FDA regulations and guidelines.
• Serve as a strategic leader in the US Labeling Review Committee (LRC), facilitating productive discussions to gain alignment across functions.
• Lead the development of product labeling artwork by providing clear, strategic regulatory input on content, layout, and visual elements.
• Act as the go-to expert for regulatory labeling matters, providing guidance and oversight to the US Labeling Scientist and other teams as needed.
• Engage in TPVP, TCLP, and CCDS discussions to support development of competitive US labeling.
• Provide competitive labeling landscape for reference in labeling development.
• Participate in process improvements to enhance efficiency of labeling development and maintenance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree