Associate Director, Global Regulator Strategy, Neuroscience

Role Summary

Associate Director, Global Regulatory Strategy, Neuroscience. Leadership responsibility for global regulatory strategy within a development team, serving as team lead or co-lead of marketing application submission teams for indications at the regulatory filing stage; developing strategy and content for global dossiers.

Responsibilities

• Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries
• Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans
• 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 global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
• 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.

Qualifications

• Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.
• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
• Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
• Understanding of scientific content and complexities and good knowledge of drug development is desired.
• Experience in successfully leading teams; ability to drive quality decision-making and organize/prioritize tasks.
• Strong interpersonal skills and ability to cooperate in a cross-functional environment.
• Direct experience in developing strategy and leading teams through interactions with health authorities; track records of issue resolutions with main regulatory authorities; ability to break down complex, scientific content.
• Ability to negotiate with and influence others; facilitate issue resolution and conflict management.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience communicating regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership and governing bodies.
• Ability to coordinate global activities and represent department functions on project teams in a matrix organization.
• Experience as a member of GRTs or project working groups; experience developing strategy for product partnerships (out-licensing, divestiture, co-development, in-licensing, acquisitions).
• Experience using leadership techniques to drive a team through stages of development.

Additional Qualifications

• Strong team player, able to work across boundaries; communicates with clarity and honesty.
• Demonstrates ownership of results and sets high expectations; seeks continuous improvement.

Travel

Occasional domestic and international travel (less than 10%) may be required.