Work Flexibility: Hybrid or Onsite

Permanent Hybrid role based in Carrigtwohill, Cork

What you will do:

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

What you will need:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science
• Typically a minimum of 2 years’ experience
• MS or RAC(s) preferred

Travel Percentage: None