Global Head, Regulatory Affairs - PDx

Posted 4 days agoViewed

View full description

💎 Seniority level: Lead, 10+ years

📍 Location: Canada

🔍 Industry: Pharmaceutical

🏢 Company: GEHC_ExternalSite

🗣️ Languages: English

⏳ Experience: 10+ years

🪄 Skills: LeadershipProject ManagementData AnalysisPeople ManagementCross-functional Team LeadershipStrategic ManagementCommunication SkillsAnalytical SkillsProblem SolvingAgile methodologiesMentoringNegotiationWritten communicationComplianceInterpersonal skillsVerbal communicationTrainingQuality AssuranceRisk ManagementTeam managementStakeholder managementChange ManagementBudget management

Requirements:

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.
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English

Responsibilities:

Provide strategic regulatory direction to the PDx business
Develop and implement regulatory strategies
Drive effective execution of global regulatory strategy
Monitor external landscape to formulate regulatory strategies
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.
Provide leadership during regulatory inspections (US FDA, China NMPA, MDSAP, EU MDR, etc.).
Build global network of regulatory professionals across the company
Recruit, mentor and train direct and indirect reports on activities within areas of responsibility.

Apply