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

Davita Inc.; Smyrna (GA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Join Davita Inc. as a Senior Labeling Strategist and play a pivotal role in shaping product labeling strategies within regulatory frameworks. Collaborate with various teams to ensure compliance with FDA guidelines and enhance product marketability while leading key initiatives in labeling development. A unique opportunity to drive regulatory excellence in a supportive hybrid work environment.

Qualifications

• Minimum 7 years' experience in Regulatory Affairs, 5 years in Regulatory labeling strategy.
• Expert knowledge of US laws and regulations.
• 2 years of Regulatory advertising and promotion experience.

Responsibilities

• Lead the development and maintenance of US product labeling.
• Facilitate discussions in the Labeling Review Committee.
• Provide regulatory guidance on labeling matters.

Skills

Leadership

Communication

Interpersonal skills

Strategic assessment

Risk navigation

Education

Bachelor's degree in health sciences, business or related field

Job description

JOB DESCRIPTION

Make your mark for patients

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.

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 Strategist (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 Strategist (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.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law.

UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] 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.