Associate Director, Global Regulator Strategy, Neuroscience

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Associate Director, Global Regulatory Strategy, Neuroscience

Position Summary:

The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.

Position 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.

Education / Experience Requirements

• 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 Competency Requirements

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

• Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers 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; demonstrated ability to break down complex, scientific content into logical components.

• Demonstrated ability to negotiate with and influence others. Ability to facilitate issue resolution and conflict management.

• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.

• Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.

• Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.

• Experience