Operations/Project Management - Project Manager - General II

Job Summary

The US and/or Global Regulatory Lead, Neuroscience (Director-GRL) position at Pinnacle Method Consulting involves leadership responsibility for global regulatory strategy within a development team (DT) and/or Global Regulatory Team. The role requires serving as a team lead or co-lead of marketing application submission teams for indications at the regulatory filing stage, supporting the preparation of, and participating in / leading (as appropriate), key Health Authorities (HA) interactions, and ensuring consistent positions on common issues are presented to the FDA and global HA.

Key Competencies

• Good knowledge and understanding of scientific content and complexities of drug development in neuroscience/psychiatry
• 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

Qualifications

• Hybrid work (50/50) is preferred, 100% remote acceptable
• 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

Other Qualifications

• Experience with 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

Benefits

Hybrid work (50/50) is preferred, 100% remote acceptable.

Pay

Bill rate: $73/hr

Schedule

Remote