Senior Regulatory Affairs Specialist page is loaded## Senior Regulatory Affairs Specialistlocations: Cork, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R******Work Flexibility: Hybrid or Onsite**(23 month fixed term contract)****Key Areas of Responsibility:*** 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**Education / Work Experience:*** BS in Engineering, Science, or related degree; or MS in Regulatory Science* Typically a minimum of 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#IJTravel Percentage: None
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