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
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
Qualifications
BS in Engineering, Science, or related degree; or MS in Regulatory Science
