Associate - Global Regulatory Affairs Operations

Associate GRAAS Operations

Career Category

Regulatory

Job Description

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 

.

Experience Level

Mid Level