Work Flexibility: Hybrid

Job responsibilities

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

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 stakeholdersAssists in the preparation for meetings with regulatory agencies and other stakeholdersAssists 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 organizationSeeks out diverse ideas, opinions, and insights, and applies them in the workplaceConnects and relates well with people who think and act differently than oneselfEmbraces scrutiny and accepts feedback as opportunity to learn and improve

Qualifications

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

5-8 yrs experience

Travel Percentage: 10%