Global Regulatory Strategist

Responsibilities

Global Regulatory Strategist for antithrombotic assets will have leadership responsibility for global regulatory strategy within the Innovative Medicine 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. Contribute in developing target labeling. 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 Global Regulatory Subteam, develop global submission plans and HA interaction plans. Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HAdeadlines.

Qualifications

PhD or MS in regulatory science with 4+ years in the pharmaceutical industry.

Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMD and across alliance.

Experience as a member of Global Regulatory Subteam, project working groups, or comparable experience.

Experience with developing regulatory strategiesin coordination with clinical plans and marketing objectives.

Experience with communication of regulatory strategy, issues, and risks in written and verbal format to MPD SLT and other governing bodies.

Experience utilizing leadership techniques to drive a team through the stages of teamdevelopment.

Experience coordinating communications within teams and across functions.

Experience applying project management techniques within teams. Experience in effectively managing meetings.

Demonstrated ability to breakdown complex, scientific content into logical components.

Demonstrated ability to coordinate global activities.

Demonstrated ability to facilitate issue resolution and conflict management.

Demonstrated ability to drive quality decision-making. Demonstrated ability to organize/prioritize tasks.

Demonstrated ability to negotiate with and influence others.

Understanding of strategic and tactical role for the antithrombotic drug development process.

Understanding of general global regulatory requirements for drugs in development.

Understanding of R&D process and specific regulatory responsibilities/deliverables for the company Decision Points