Regulatory Affairs Specialist

12 month Hybrid contract in our Innovation Centre 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
• Provides knowledge and guidance on preapproval inspections GCP inspections and clinical investigator relationships
• Identifies monitors and submits applicable reports or notifications to regulatory authorities during the clinical research process
• Provides regulatory information and guidance for proposed product claims/labeling
• Ensures that the clinical and nonclinical data in conjunction with regulatory strategy are consistent with the regulatory requirements and support the proposed product claims
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you will need:

• BS in Engineering Science or related degree; or MS in Regulatory Science
• Typically a minimum of 0-2 years experience
• MS or RAC(s) preferred

Knowledge / Competencies:

• Project management writing coordination and execution of regulatory items
• Perform technical and scientific regulatory activities
• Usually works with minimum supervision conferring with superior on unusual matters
• Assignments are broad in nature requiring originality and ingenuity
• Has some latitude for unreviewed action or decision