Operations/Project Management - Project Manager - General II

Position Summary / Objective

Leadership responsibility for global regulatory strategy within a development team (DT) and/or Global Regulatory Team.

Position Responsibilities

• 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.
• Support the preparation of, and participate in / lead (as appropriate), key Health Authorities (HA) interactions.
• Assure consistent positions on common issues are presented to the FDA and global HA.
• Review and approve content of responses to queries from HAs.
• 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.

Key Competency Requirements

• Good knowledge and understanding of scientific content and complexities of drug development in neuroscience/psychiatry is desired.
• 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.
• Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
• Experience in successfully leading teams; Demonstrated ability to drive quality decision-making.
• Demonstrated ability to organize / prioritize tasks.
• Demonstrated ability to negotiate with and influence others.
• Demonstrated ability to facilitate issue resolution and conflict management.
• 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.
• 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 as a member of GRTs, project working groups, or comparable experience.
• Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
• Experience utilizing leadership techniques to drive a team through the stages of team development.

Other Qualifications

• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.
• Communicates opinions, facts and thoughts with clarity, transparency and honesty.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.

Additional Position Details

• Experience: 4-7 years
• Hiring Manager priorities: NDA or sNDA experience including labeling negotiation, leading FDA meetings, experience working in psychiatry development of broader neuroscience, understanding of the US FDA, Global Regulatory Team model.
• This role reports to a VP.
• Hybrid work (50/50) is preferred, 100% remote acceptable for candidates in the United States.
• Travel required: Yes.