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Regulatory Affairs Manager
Apply locations Cork, Ireland time type Full time posted on Posted Yesterday job requisition id R543519 Work Flexibility: Onsite
Regulatory Affairs Manager- candidate can come from Quality or Regulatory background.
This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family.
Key Areas of Responsibility:
* Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
* Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
* Provides guidance to integrate regulatory considerations into global product entry and exit strategy
* Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
* Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
* Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
* Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
* Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
* Negotiates with regulatory authorities on complex issues throughout the product lifecycle
* Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
* Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
* Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
* Provides strategic input and technical guidance on global regulatory requirements to product development terms
* Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
* Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
* Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
* Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
* Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships
* Provides regulatory guidance on strategy for proposed product claims/labeling
* Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
* Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
* Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
* Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
Education / Work Experience:
* BS in a science, engineering or related Advanced degree preferred
* Minimum of 8 years experience
* People Management experience required
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Travel Percentage: 20%
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