Description
**Role -** GSIM Regulatory Data Management – Associate
**Organization** -Global Regulatory Affairs Execution Team
**Team** **-G** **lobal Submission & Information Management (GSIM)**
**Group Purpose** **-** Ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities.
**Job Summary**
• Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates
• Integrations:
• Updating the Regulatory Submissions and Document Information Management System (RSDIMS) and Analytics:
• Metrics compilation and analysis
• Liaison with internal customers to improve efficiencies within RDA and other functional areas
• Manages requests within the Regulatory Intake System to comply with data management of a GMP system
**Key Activities**
• Maintain Regulatory document management and tracking systems
• Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
• Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage
• Point of contact between Regulatory Representatives/CMC and publishing teams
• Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions
• Ensuring Regulatory compliance with SOPs and Regulatory authorities
• Provide support to RDA team members and other functional areas, including vendors
• Collaboration with external partners/outsourced CROs
• Manage 1572 forms for FDA submission
**Knowledge and Skills**
• Working in teams
• Minimal familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• Basic understanding of the Veeva Vault system
• Good written and verbal communication skills and detail oriented
• Independent time management and prioritization skills
• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
• Critical thinking skills
• Appropriate software skills as required
**Education & Experience (Basic)**
Bachelor’s degree
OR
Associate’s degree & 4 years of directly related experience
OR
High school diploma / GED & 6 years of directly related experience
**Education & Experience (Preferred)**
• Experience in an operationally focused role within Regulatory Affairs
