Global Head, Regulatory Affairs – PDx

Job title:

Global Head, Regulatory Affairs – PDx

Company

GE HealthCare

Job description

Job Description SummaryJob DescriptionResponsibilities:Member of the PDx Business and Global Quality and Regulatory Affairs Senior Leadership Teams. Provide strategic regulatory direction to the PDx business, advising on pre-market and post market regulatory matters, delivering world-class service across the total product lifecycle for the business. Work closely with senior executives (e.g. Chief Quality & Regulatory Officer, PDx Business Unit CEO, Quality, Legal, Marketing, R&D, Manufacturing, Service) to develop and implement regulatory strategies, policies and positions that are consistent with the business vision and global regulatory requirements; provide proactive regulatory advice, expertise and data on a global basis to guide management & drive appropriate decisions Drive effective execution of global regulatory strategy, including product submissions, change assessments, updates, Manufacturing Authorization Certificate process, Chemical and Manufacturing Controls (CMC) process, advertising and promotion, pre and post market regulator interface. Monitor external landscape to formulate regulatory strategies and take into consideration the impact of business decisions, work closely with regulatory bodies globally. Shape external regulatory environment through direct interaction with regulators and trade associations. Develop and implement strategies improve existing processes and champion implementation of new initiatives across Global Regulatory Affairs to ensure consistency, compliance and regulatory excellence. Comment on, and ensure appropriate company review of draft legislation, regulation, and guidance affecting GE Healthcare Analyze and share regulatory intelligence and provide impact assessment and actions required to ensure compliance to minimize and eliminate impact to business continuity.Provide leadership during regulatory inspections (US FDA, China NMPA, MDSAP, EU MDR, etc.). Build global network of regulatory professionals across the company; lead regulatory colleagues across GE Healthcare to ensure a consistent approach to regulatory authorities is adopted throughout the business. Recruit, mentor and train direct and indirect reports on activities within areas of responsibility. Coach Regulatory Affairs Leaders across her/his own organization and across the Global Regulatory Affairs organization to develop effective regulatory strategies that meet business goals.Qualifications:Bachelor Degree in Science, Engineering, Regulatory Affairs (or other related field) & minimum of 10 years’ experience in the pharmaceutical industry or with pharmaceutical regulatory agencies; OR minimum of 16 years progressive regulatory affairs experience in the pharmaceutical industry or with pharmaceutical regulatory agencies, including knowledge and experience applying drug laws and regulations for product registration, inspections, adverse event reporting and product recalls. Minimum of 5 years proven leadership experience including hiring, training, coaching and performance management activities. Extensive knowledge of global regulatory requirements, including Canada, China, Europe, Japan, Korea, Latin America and United States. Extensive experience guiding and managing complex pre-market and post-market regulatory matters globally. Demonstrated experience interfacing with regulatory bodies Extensive experience in shaping and influencing regulations and guidance documents globally, working with industry groups and regulators. Experience with Quality Management System development and application. Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness. Ability to influence and make recommendations at all levels of the company. Demonstrated project management skills to establish strategic goals and to prioritize, plan, delegate and evaluate deliverables. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements. Prior experience using spreadsheet and presentation software. Must be willing to travel up to 25% of time.

Desired Characteristics:Regulatory Affairs Certification (RAPS RAC). Advanced degree in Regulatory Affairs, or a scientific, technology or legal discipline Significant experience interfacing with external regulatory agencies (e.g. US FDA) on pre-market and post-market issues, to detect trends and align priorities as needed. Demonstrated experience with a new product introduction process (i.e. new product launches) Demonstrated experience working with industry trade associations and standards organizations in shaping regulatory and technical requirements. Experience with drug advertising and promotion regulations and best practices. Experience working across cultures/regions/sites. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.Additional InformationRelocation Assistance Provided: No

Expected salary

Location

Quebec City, QC

Job date

Sun, 02 Mar 2025 00:00:55 GMT

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