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+ 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
#IJ
Travel Percentage: None