Junior Regulatory Specialist(Pharma Or Medical Device)

Rate:$37 to $46/hr on W2

LocationTemecula, CA

TitleRegulatory Operations Specialist

Full

DescriptionDescription: Provides support to the Regulatory Affairs team and is responsible for validating Global Product Registration (GPR) Library approval record metadata.

Leverage the Excel tracking sheets and Country Specific Approval record templates to validate the Metadata of the individual approval records.

Identify out of syncs between specific metadata fields and the approval records.

Identify approval records that need clarification to reconcile the information and communicate with the contact for the in-country affiliates for resolution.

Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives.

Run blocked order reports, coordinate block order resolution with Regulatory Affairs Specialists, solve routine issues with system and processes and manage resolution of blocked orders within tight timelines.

Supports all business segment initiatives as identified by divisional management.

Participates in projects affecting GTS licenses.

SkillsQualifications: Bachelor’s degree

1+ years of experience in a similar role from a regulated manufacturing environment (i.e. medical device, pharmaceutical, etc)

Proficient with MS Office suite (Word, Excel, Outlook)

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Medical device experience preferred

Previous experience working in a highly matrixed and geographically diverse business environment preferred