Junto HLS has been exclusively engaged by Regulatory Leadership at a Top 20 pharma to recruit a Director, Global Labeling.
- Continue building your Labeling and Labeling infrastructure (people/ process/ technology) expertise
- Your experience leading change, building something from scratch and operating independently
- Why Needed – This is a true “build” – Our client is building labeling infrastructure to get ready for marketing applications
- Work on impactful, life-saving medications, well positioned vs. unmet medical need and competitors
- Establish the strategic direction and oversight of departmental activities to assess, draft, review, finalize and maintain product labeling, as well as regulatory compliance initiatives and activities that may impact labeling strategy, throughout the product life-cycle, on a global basis.
- Leads the regulatory activities pertaining to the development of product labeling for all global programs.
- Lead the development of labeling material through cross-functional collaboration according to agreed timelines and established processes with a Quality-driven mindset.
- Establishes and monitors compliance with internal processes, e.g., implementation of CCDS information into product labeling, identifies issues and defines escalation pathways as needed.
- In coordination with stakeholders, ensures compliance-related issues are identified and resolved.
- Liaises with external partners when needed, tracks and monitors compliance to Labeling Agreements as established.
- Establishes and manages relationships with business partners and Affiliates to ensure label control, efficient label creation and continuous improvement of programs to meet business needs and regulatory requirements.
- Provides support to outsourced labeling activities, as needed.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.