Regulatory Affairs Coordinator Job

REGULATORY AFFAIRS COORDINATOR needed for a CONTRACT opportunity with Yoh's client located in THOUSAND OAKS, CA.

The Big Picture - Top Skills You Should Possess:
- TAs/CMC

What You'll Be Doing:
- Support the compilation, submission and archiving of regulatory dossiers
- Maintain regulatory document management systems and tracking systems
- Maintain core dossier components
- Quality control of regulatory dossiers, archive and tracking systems
- Primary Regulatory Operations point of contact between TAs/CMC and publishing teams Key Activities
- GRT deliverables: Regulatory Operations GRT representative; primary Regulatory Operations point of contact between publishers and the TAsinput into planning and tracking of submission timelines; Point of contact with TAs/CMC/PMSO regarding status of submission components; Cross-TA information sharing and liaison with TAs/CMC for submission prioritization;
- Maintenance of regulatory tracking systems: Data entry, administration of, and reporting from regulatory registration tracking system (IMR); maintenance of product history logs;
- System administration: administration of document management systems; EPIC dictionary maintenance; maintenance of team Sharepoint sites and associated documentation;
- Electronic document management of ongoing submissions: collation of dossier components into document management system; virtual document build; literature reference sourcing; maintenance of EPIC core components for Emerging Markets
- Regulatory archive: submission of regulatory dossiers, agency correspondence and records of contact to regulatory archive; upload to document management system; maintenance of product history documents; IMR data entry and document linking; maintenance of virtual documents for currently registered details
- Quality control: submission ready components and submission dossiers; IMR data entries and links; regulatory archive locations and file naming
- Information requests: fill internal requests for information and documentation
- Metrics generation: liaison with internal customers to determine key performance and compliance indicators; liaise with reporting groups for IMR outputs
- Templates: development of standards and templates for routine reports; creation and maintenance of work request templates
- External partners and vendors: external partner document exchange; translation vendors
- Training: contribute to the development and roll out of training documentation and e-manuals

Knowledge and Skills

What You Need to Bring to the Table:
- Working in teams
- Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations and Regulatory Guidance
- Use of document management systems and databases
- Good written and verbal communication skills
- General understanding of industry practice and standards
- Attention to detail
- Relationship building
- Time and project management skills
- Organizational skills

RECRUITER: Mary Nguyen

Yoh, a DayJ2W: CLINICAL

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