Regulatory Affairs Consultant - Labeling (6 month temp)

Exciting chance to join Parexel for a 6-month temporary position, collaborating closely with a major client! In the Global Labeling team, you'll lead labeling strategy and ensure that labeling documents meet high-quality standards and compliance for the safe and effective use of our products by patients and healthcare providers worldwide.

The US Senior Labeling Scientist plays a pivotal role in shaping the strategic direction of product labeling, working closely with our client’s 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 ensures that local labeling not only meets FDA guidelines but also supports competitive positioning, market access, and effective product promotion in the US market.

Key responsibilities include:

• 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. Partner with the US Regulatory Science Lead and cross-functional subject matter experts to drive consistency and regulatory compliance across product labeling.

• 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. Collaborate closely with the Regulatory A&P representative to ensure that labeling is optimized to support both regulatory compliance and marketing objectives.

• 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.

• Impact on Product Promotion: Ensure 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.

• 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. Collaborate on the maintenance of establishment registrations, drug listings, FDA submission documents, and artwork reviews to ensure ongoing compliance and readiness for regulatory submissions.

By taking a strategic, collaborative approach to labeling development, the US Senior Labeling Scientist drives regulatory excellence while enabling the business to achieve key objectives related to product promotion, market access, and compliance.

• Minimum of 7 years experience in Regulatory Affairs and 5 years experience in Regulatory labeling strategy.  In addition, 2 years of Regulatory advertising and promotion review experience preferred.

• Expert knowledge of US laws, regulations, and guidances related to pharmaceutical product labeling development

• Strong leadership, communication, interpersonal skills, and an ability to strategically both assess and navigate risk

• Ability to work collaboratively and influence cross-functional teams

• Ability to manage multiple projects and prioritize competing deadlines

• Ability to think strategically and creatively to regulatory challenges

MAJOR RESPONSIBILITIES

• US Regulatory expert regarding requirements for US regulation of drug labeling.  

• Ensure all marketed product labeling adhere to regulatory requirements.

• Engages in TPVP, TCLP, and CCDS discussions to support development of competitive US labeling.

• Leads development and maintenance of US product labeling consistent with the CCDS and FDA regulations/guidelines

• Leads Labeling Review Committee meetings to gain labeling alignment among cross-functional subject matter experts.

• Providing competitive labeling landscape for reference in labeling development.

• Participate in process improvements to enhance efficiency of labeling development and maintenance.

• Communicate FDA requirements and trends to other departments involved in the preparation or review of product labeling.

• Ensures product labeling is managed in accordance with applicable procedures utilizing required document management systems.

• Ensures labeling documents in FDA submissions are complete, accurate, and compliant with FDA submission requirements.

• Provide support to fellow Labeling Scientists responsible for establishment registrations, drug listing, FDA submission document preparation, and artwork reviews.

Clients located in EST based in the US or Canada are preferred due to the location of the client, but strong candidates in other US or Canada time zones may be considered.