Principal Regulatory Affairs Specialist
Job Details
permanent
Cork, Munster, Ireland
Stryker European Operations Limited
20-03-2024
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Full Job Description
Work Flexibility: Hybrid or Onsite
Permanent
role in our Innovation Centre
What you
will do:
- Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
- Participates in advocacy activities of a more advanced strategic nature
- 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
- Manages electronic (eCTD) and paper registration development
- 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
What you will need:
- BS in Engineering, Science, or related Advanced degree desired or MS in Regulatory Science
- Typically a minimum of 10 years experience
- RAC(s) desired
- Articulates the organization's strategic vision in a manner that enables others to execute plans, tactics, and actions
- Continually identifies and informs appropriate individuals on emerging trends, opportunities, and threats
- Leverages a well-grounded knowledge of applicable laws, regulations and policies to develop and execute plans and programs
- Ensures strategies, analyses, and plans consider anticipated long-range requirements and are not just based on the current situation
- Makes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources
- Proactively manages and monitors progress against desired outcomes including working with others to establish and adjust contingency plans, revising and adapting processes, communicating success and learning from mistakes
Travel Percentage: 20%