Associate Director, Global Regulator Strategy, Neuroscience

Role Summary

Associate Director, Global Regulatory Strategy, Neuroscience — Lead global regulatory strategy within a development team, serving as team lead or co-lead of marketing application submission teams for regulatory filing indications, and help develop strategy and content for global dossiers.

Responsibilities

• Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Ensure 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 meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input
• Collaborate with the global regulatory team (GRT) to 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 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

Key Competencies

• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in product development and commercialization
• Knowledge of global regulatory policies, laws, regulations, and guidelines for drug development and approval
• Strong scientific content understanding and knowledge of drug development
• Experience in leading teams and driving quality decision-making; ability to organize and prioritize tasks
• Interpersonal skills and ability to collaborate cross-functionally
• Direct experience developing strategy and leading teams through interactions with health authorities; track record of issue resolution with regulators; ability to simplify complex scientific content
• Negotiation, influence, issue resolution, and conflict management skills
• Experience documenting regulatory strategies in coordination with clinical plans and marketing objectives
• Experience communicating regulatory strategy, issues, and risks to regulatory leadership and governing bodies
• Ability to represent department functions on project teams in a matrix organization; ability to coordinate global activities
• Experience as a member of GRTs or project groups; experience developing strategy for product partnerships (out-licensing, divestiture, co-development, in-licensing, acquisitions)
• Leadership skills to guide a team through development stages

Additional Qualifications

• Strong collaboration across internal and external resources; clear, transparent communication
• Ownership of results within and beyond area of responsibility
• Sets clear, high expectations and holds self and others accountable; seeks continuous improvement

Travel

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