Requisition No.: 23337-1
Status: Full Time
Project Duration: 6 months
• “Global Regulatory Strategy Lead (GRTL) Marketed Product Development will have leadership responsibility for global regulatory strategy within the Marketed Product portfolio. Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Develop target labeling and co-lead the cross functional labeling team. Ensure consistent positions are presented in responses to global Health Authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the GRT, develop global submission plans and HA interaction plans. Provide input into the development of protocol synopses and protocols. Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
o Demonstrated ability to coordinate global activities.
o Demonstrated ability to facilitate issue resolution and I conflict management.
o Demonstrated ability to drive quality decision-making. Demonstrated ability to organize/prioritize tasks.
o Demonstrated ability to negotiate with and influence others.
o Understanding of strategic and tactical role of MPD in the drug development process.
o Understanding of general global regulatory requirements for drugs in development.
o Understanding of PD&C process and specific MPD responsibilities/deliverables at PD&C Decision Points”
o Experience as a member of GRTs, project working groups, or comparable experience.
o Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
o Experience with communication of regulatory strategy, issues, and risks in written and verbal format to MPD SLT and other governing bodies.
o Experience utilizing leadership techniques to drive a team through the stages of team development.
o Experience coordinating communications within teams and across functions.
o Experience applying project management techniques within teams.
o Experience in effectively managing meetings.