Aliso Viejo, California, USA
5 days ago
VP, Global Regulatory Affairs
Assume worldwide responsibility, while working closely with the SVP, Global Quality & Regulatory Affairs, to map the optimal and contingent regulatory strategies to support product registrations, compliance with domestic and international regulations and marketing message.  Obtain worldwide regulatory approvals.  Assure compliance to domestic and international regulatory requirements for all regions and supervise a global organization encompassing global regulatory affairs.  Job duties:Lead development and implementation of efficient and economical regulatory strategies for worldwide product registrations, regulatory compliance, and marketing support.Develop and facilitate collaborative relationships with domestic and international federal agencies.Lead the preparation of regulatory submissions for product registration in the U.S. and international countries.Negotiate directly with regulatory agencies and/or country distributors.Lead the Regulatory Affairs department.Inspire, motivate, and communicate vision; build consensus toward adoption of and commitment to new standards.Assess the current state of the Regulatory Affairs department (organizational structure, competencies, and skills).Provide guidance on legal and regulatory issues related to advertising, labeling, public disclosures, corporate communications, and other public relations activities.Assure timely regulatory clearances for key product launches.Develop and implement a strategic vision and tactical plans consistent with the organizational strategic objectives.Coordinate regulatory agency and notified body inspections.Promote awareness of applicable regulatory requirements.Travel as needed.Comply with applicable Laws and Regulations, adhere to Quality Management System process and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.#LI-DNI
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