Role -GSIM Regulatory Data Management - Associate
Organization - Global Regulatory Affairs Execution Team
Team -Global 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
