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Regulatory Affairs Senior Associate

Thousand Oaks, CA
Top 3 Must Have Skill Sets:
    
CMC Regulatory Experience
5 years work experience
Previous state licensure experience for pharmaceuticals in human or/veterinary

Soft skills:
Detail Oriented
Team Player (any Cross functional team experience)

Description:

Requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to its operations, or its staff.”

** Ideal candidate will have experience in state licensure **
Must have: CMC Regulatory Experience

NOT 100% remote. Local candidates needed. Candidate will be required to visit ATO campus occasionally to process state mail.

Future return to campus - TBD

To maintain current state and federal licenses for Manufacturing and Distribution operations within U.S. Jurisdictions.

Job Details: Sr. Associate Regulatory Affairs - Licensing is responsible for:
• coordinating license renewals and handling government interactions germaine to U.S. Jurisdictional licensing
• ensuring all State Manufacturer, Wholesale and Distributor licenses are maintained in accordance with State and Federal requirements
• tracking and filing necessary applications

The person in this role must:
• understand and complete State license application forms with relevant and subsidiary information
• be able to work independently
• know how and where to find needed information.

Timely and accurate submission of license applications including:
• monitoring state license renewal schedules
• completing state license applications and renewal forms
• obtaining signatures from Corporate Officers
• liaising with licensing consultants
• notarization
• working in financial systems to request checks for state licensing fees
• entering licensing information and filing licensing documentation into the regulatory document management system
• maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses

Additional responsibilities may include supporting U.S. Regional Licensing Team with the following.
• Clinical Export Reports
• Distribution Reports
• Establishment Registrations
• APR Submissions and Post Marketing Commitments (Cognos Reports)
- State wholesale and distributor license renewal procedures
- Regulatory database procedures
- Regulatory document management skills
- General application management skills & strong computer aptitude
- Attention to timeliness and accuracy

Bachelor’s degree
-- OR --
Associate’s degree & 4 years of directly related experience
-- OR --
High school diploma / GED & 6 years of directly related experience


- Experience with state license renewals and reporting
- Experience with Document Management Systems -

"This posting is for Contingent Worker, not an FTE"
 

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