Title: Biosimilars Senior Associate / Document management
Job ID: 24062
Location: Thousand Oaks, CA
Duration: 18 Months
Pay Rate Range: Depends on Experience (W-2 all inclusive rate)
Purpose and Description:
Supports Biosimilars staff with the preparation of regulatory filings and amendments with input from the Analytical and Regulatory Affairs teams. Drafts scientific, CMC, and regulatory documents that conform to global requirements, client and industry standards, and ...
Novella Clinical Resourcing has a home-based Regulatory Affairs opportunity available.
The Director of Regulatory Affairs will play a key role in the development of Medical Device submissions and the implementation of Regulatory Compliance.
S/he will develop strategies for government approval, both US and OUS of clinical and pre clinical trials, provide advice on regulatory requirements, prepare submissions, negotiate their approval, and assure that activities are carried out ...
The Director of Regulatory Affairs will play a key role in developing and implementing global Regulatory strategies to secure market access for Class II/III medical devices in coordination with key internal and external stakeholders. This individual will be the Regulatory subject matter expert for all applicable medical devices. S/he will need to identify, assess and communicate regulatory development and submission strategies, regulatory risks, interface with relevant regulatory ...
Jun 24 -
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