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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)


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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