Work Flexibility: Hybrid

What You will do -

Identifies information sources and resources for local, regional, and global regulationsCollects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related informationMonitors 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 jurisdictionResearches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activitiesAssists in the development of regulatory procedures and SOPsCollects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulationsOrganizes materials from preclinical and clinical studies for review and assists in the review processCompiles and organizes materials for pre-submission reports and communicationsAssists in the preparation of dossiers and pre-submission and submission packages for regulatory agenciesTracks the status of applications under regulatory review and provides updates to the regulatory teamMaintains logs of communication and outcomes with regulators and other relevant internal or external stakeholdersAssists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings

What you will need-

Education / Work Experience:

BS in Engineering, Science, or related degree; or MS in Regulatory Science4 + yrs experience

Knowledge / Competencies:

Time management skills, writing, coordination, and execution of basic regulatory itemsClearly conveys information to peers, supervisors, and other stakeholdersAssists in the preparation for meetings with regulatory agencies and other stakeholders; in the preparation of briefings and other information documentsCommunicates information on regulatory requirements to other departments and business unitsComposes routine communications with regulators and other key stakeholdersCreates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization

Travel Percentage: None