Global Compliance Expert

3 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €120,000 - €150,000

Regulatory Affairs Manager

Location: Cork, Ireland

The Regulatory Affairs Manager plays a critical role in ensuring the organization's products meet regulatory requirements.

Key Responsibilities:

  • Assesses links between global trends and regulatory issues to inform strategic decisions.
  • Develops and updates regulatory strategies to ensure compliance and drive business growth.
  • Provides guidance on integrating regulatory considerations into product entry and exit strategies.
  • Identifies regulatory pathways for new products and provides input to internal stakeholders.
  • Analyses proposed regulatory pathways and recommends changes or refinements based on initial outcomes.
  • Assesses market access and distribution requirements, identifying potential obstacles and developing solutions.
  • Critically assesses the impact of changing regulations on pre-approval and post-approval strategies.
  • Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
  • Establishes working relationships with government organizations impacting market access.
  • Manages the development and execution of new regulatory procedures and standard operating procedures.
  • Develops training programs to ensure organization-wide compliance.
  • Provides strategic input and technical guidance on global regulatory requirements.
  • Evaluates risks of product safety issues during clinical phases.
  • Reviews proposals to regulatory authorities on regulatory paths and clinical plans.
  • Monitors implementation of regulatory strategies relative to product safety issues.
  • Provides knowledge and analysis of pre-approval inspections and clinical investigator relationships.
  • Ensures data are consistent with regulatory requirements.
  • Leads negotiations and interactions with regulatory authorities during all stages of development.

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