Regulatory Affairs Specialist

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+ yrs 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 opportunity to learn and improve

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