Senior Global Regulatory Strategist

1 day ago

Cork, Cork, Ireland beBeeRegulatory Full time

Job Title:

A Global Regulatory Affairs Manager is required to lead our company's regulatory strategy and ensure compliance with global regulations.

  • This is a permanent role with full benefits- bonus, pension and healthcare for employee and their family.

Key Areas of Responsibility:

  • Regulatory Strategy Development:
    • Develops and updates global, regional and multi-country regulatory strategies
    • Aligns regulatory strategies to organizational strategies
  • Regulatory Compliance:
    • Ensures compliance with federal, provincial/territorial/state, reimbursement, purchasing groups, etc.
  • Market Access:
    • Identifies regulatory pathways for initial product designs
    • Analyzes the adequacy of proposed regulatory pathways and strategy
  • Negotiations:
    • Negotiates with regulatory authorities on complex issues throughout the product lifecycle
  • Team Management:
    • Establishes working relationships and interfaces with multiple government and non-government organizations
    • Manages the development and execution of new regulatory procedures and standard operating procedures
  • Training and Guidance:
    • Develops and manages programs that train stakeholders on current and new regulatory requirements
  • Clinical Safety:
    • Evaluates risks of product and clinical safety issues during clinical phases
  • Preliminary Inspection:
    • Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
  • Claim Strategy:
    • Provides regulatory guidance on strategy for proposed product claims/labeling
  • Review Process:
    • Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
  • Internal Review:
    • Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
  • Negotiation Team Lead:
    • Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process

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