Position: Global Regulatory Lead

Division: Drug Development / Global Regulatory Sciences

Location: Remote

Duration: 12 Months Contract

Description:

This role will report to a VP. Please make this a priority and be certain that your team thoroughly vets your candidates before submitting them.

Please review the entire job description, however, the Hiring manager has pointed out that the following is a priority:

NDA or sNDA experience including labelling negotiation, leading FDA meetings, experience working in psychiatry development of broader neuroscience, understanding of the US FDA, and Global Regulatory Team model.

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 the 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 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, DSLRs, 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.

Degree Requirements

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS

Experience Requirements:

Significant experience in regulatory strategy and science (e.g. > 4-7 years)

Key Competency Requirements:

Required:

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

• Understand strategic and tactical roles 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 team strengths 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 the regulatory senior leadership team and other governing bodies.

• Ability to broadly represent department functions on a 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.

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

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.

• Set clear and high expectations and hold self and others accountable for decisions and results achieved.

• Look for opportunities for continuous improvement.