Regulatory Affairs Expert

2 weeks ago

Cork, Cork, Ireland beBeeRegulatory Full time €55,000 - €85,000
Job Title: Staff Specialist, Regulatory Affairs

About the Role:

As a key member of our regulatory affairs team, you will play a critical role in ensuring our products comply with regulatory requirements.

  • Regulatory Intelligence: Assess and analyze regulatory information to inform local, regional, and global regulatory strategies.
  • Advocacy Activities: Participate in technical and/or tactical advocacy activities to drive change.
  • Regulatory Environment: Evaluate and provide internal advice on the regulatory environment throughout the product lifecycle to ensure compliance.
  • Emerging Issues: Anticipate and address regulatory obstacles and emerging issues.
  • Market Access: Identify requirements and potential obstacles for market access distribution.
  • Regulatory Strategy: Assist in developing and updating regulatory strategy based on changes.
  • Product Evaluation: Evaluate proposed products for regulatory classification and jurisdiction.
  • Regulatory Submission: Determine requirements and options for regulatory submission, approval pathways, and compliance activities.
  • Regulatory Information: Provide regulatory information and guidance for product development and planning throughout the product lifecycle.
  • Negotiation: Negotiate with regulatory authorities throughout the product lifecycle.
  • Training: Help train stakeholders on current and new regulatory requirements.
  • SOP Development: Assist other departments in developing SOPs to ensure regulatory compliance.
  • Technical Guidance: Provide regulatory input and technical guidance on global regulatory requirements.
  • Quality Data: Advise on quality, preclinical, and clinical data to meet applicable regulations.
  • Document Acceptability: Assess the acceptability of quality, preclinical, and clinical documents for submission filing.
  • Change Management: Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions.
  • Preapproval Inspections: Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
  • Clinical Research: Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
  • Submission Preparation: Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements.

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