Gaps may exist in staffing within pharmaceutical Regulatory Affairs departments due to a company’s project load, scope of strategic and development objectives, or financial limitations and uncertainties. Regulatory Gap Services, LLC will help develop strategy, plan for and attend meetings with health authorities, or just write a regulatory document to assist your company to move past a submission deadline. RGS will partner with your clinical development team in all aspects of their work from defining an accepted protocol endpoint or investigational plan, joining in investigator meetings or managing Safety Data Monitoring Boards. Regulatory Gap Services, LLC provides the bridge across gaps in strategy planning to submission oversight.

As a member of the senior management team, responsible for overseeing the development and execution of global regulatory strategies in order to achieve the earliest possible approvals of all regulatory submissions, and within the context of analyzing global regulatory requirements and procedures, assure cost effectiveness and compliance. The VP of Global Regulatory Affairs is required to lead in establishing creative, constructive interactions with regulatory agencies to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.

Responsible for leading and coordinating global regulatory strategies across three major ICH regions to facilitate development and regulatory approval of new drugs and biologics in these regions, in collaboration with Chugai HQ (Japan) and Chugai's other affiliates and development partners. Provide strategic and operational management of US/North American regulatory affairs for Chugai's global clinical programs, including the planning and execution of health authority meetings, regulatory submissions, CMC regulatory affairs, and regulatory compliance, as well as communication and management of regulatory consultants, CROs, and other vendors.

As a member of the senior management team, responsible for overseeing the development and execution of global regulatory strategies in order to achieve the earliest possible approvals of all regulatory submissions, and within the context of analyzing global regulatory requirements and procedures, assure cost effectiveness and compliance. The VP of Global Regulatory Affairs is required to lead in establishing creative, constructive interactions with regulatory agencies to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.

Provide direct management, strategic leadership and FDA liaison guidance and mentoring to Project Directors in US Regulatory Affairs, while at the same time leading US professionals towards integration with global development requirements. Accountable for assuring optimal content and focus for FDA submissions, meetings, SPAs and requests for CAC review. Provide regulatory leadership from US affiliate to Danish headquarters in a variety of therapeutic areas, including hemostasis, women’s health, oncology, diabetes and obesity.

As Vice President, help clients to effectively define the best global Regulatory Affairs strategic objectives and effectively meet with health authorities to assure concurrence to plans to achieve those objectives.

Provide strategic global regulatory direction and operational leadership to the company for development and registration, pharmacovigilance, compliance assurance and regulatory due diligence

Various leadership positions in Risk Management, Global project leadership/management and in Regulatory Affairs. In addition, Medical Affairs and Medicinal Chemistry