Regulatory Affairs Specialist
Apply locations: Cork, Carrigtwohill, Anngrove North SEO, Limerick, Limerick Raheen Business Park
Time Type: Full time
Posted on: Posted 2 Days Ago
Job Requisition ID: R532011
Work Flexibility: Hybrid
Key Areas of Responsibility:
* Identifies information sources and resources for local, regional, and global regulations
* Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information
* Monitors the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.)
* Provides information used to evaluate proposed products for regulatory classification and jurisdiction
* Researches requirements (local, national, international), applicable guidance and standards, and options for regulatory submissions, approval pathways, and compliance activities
* Assists in the development of regulatory procedures and SOPs
* Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations
* Organizes materials from preclinical and clinical studies for review and assists in the review process
* Compiles and organizes materials for pre-submission reports and communications
* Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies
* Tracks the status of applications under regulatory review and provides updates to the regulatory team
* Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
* Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
Education / Work Experience:
* BS in Engineering, Science, or related degree; or MS in Regulatory Science
* 0+ years experience
Knowledge / Competencies:
* Time management skills, writing, coordination, and execution of basic regulatory items
* Coordinate and support technical and scientific regulatory activities
* Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility
* Some evaluation, originality, or ingenuity is required
* Clearly conveys information to peers, supervisors, and other stakeholders
* Assists in the preparation for meetings with regulatory agencies and other stakeholders
* Assists in the preparation of briefings and other information documents
* Communicates information on regulatory requirements to other departments and business units
* Composes routine communications with regulators and other key stakeholders
* Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization
* Seeks out diverse ideas, opinions, and insights, and applies them in the workplace
* Connects and relates well with people who think and act differently than oneself
* Embraces scrutiny and accepts feedback as an opportunity to learn and improve
Travel Percentage: None
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