Associate GRAAS Operations
Associate GRAAS Operations
India - Hyderabad Apply NowRole -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, externalpartnersand regulatory authorities.
Job Summary
•Monitoring data quality/health, including collaboration with other internal functions tomaintainplanned 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 tocomply withdata management of a GMP system
Key Activities
•MaintainRegulatory document management and tracking systems
•Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
•Responsible formaintainingthe 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 attitudedemonstratingtact, diplomacy, and respect
•Critical thinking skills
•Appropriate softwareskills asrequired
Education & Experience (Basic)
Bachelor’s degree
OR
Associate’s degree & 4 years ofdirectly relatedexperience
OR
High school diploma / GED & 6 years ofdirectly relatedexperience
Education & Experience (Preferred)
•Experience in an operationally focused role within Regulatory Affairs
