Job Postings

 

Date Posted

Company

Position

  01/19/2022 Duke Univ. Office of Regulatory Affairs and Quality Regulatory Affairs Scientist

Under the direction of the Director/Associate Director of Regulatory Affairs, this position involves providing guidance and assistance to Duke University investigators and study teams who need US Food and Drug Administration (FDA) oversight for their research projects. It encompasses working on FDA applications for a diverse portfolio of products with a focus on pre-market submissions for drugs, biologics, devices, and tobacco products. Projects can also entail meetings with FDA and helping to ensure compliant maintenance of effective FDA applications. Other duties will include training and assistance for investigational staff.

Requisition Number:  170915

 
  11/08/2021 Dompe Regulatory Affairs Manager US

Lead advertising & promotion activities. - Manage activities and communication are consistent with USPI and are in compliance with applicable laws, guidelines and Dompé policies; - Represent the Regulatory Affairs at PRC (Product Review Committee) and be responsible to revise, approve and submit materials for Dompé’s breakthrough therapy, the first-ever ophthalmic biologic product for patients suffering from a rare eye disease; - Direct the regulatory review of non-promotional scientific information, and external communication materials, including media information - Improve the strategies for FDA promotional submission, working with both US and HQ team - Support senior director regulatory affairs for BLA maintenance activities such as submission of PAS, CBE-30, Annual Report, Distribution Report etc. - Maintain current awareness of evolving regulation and interpretation, working closely north America regulatory affairs leader.

 
  10/13/2021 MAE Group Regulatory Affairs Specialist II

As a lead member of the regulatory affairs team, you will provide timely and valued regulatory support by owning the following tasks with minimal supervision: *Develop regulatory strategies based on client target market(s) *Review all documentation provided by client in preparation of product application to ensure compliance to standards, guidance documents, etc. and ensure most accurate submission to minimize RAI and/or RTA notifications. *Prepare regulatory submissions for global markets, submit to agencies and gain approval. *Conduct research and interface with quality systems and clinical affairs staff as required in support of product application and approval.

For further information or to apply, please contact Brooke Hamby at [email protected]

 
 

 

 

 

Senior Manager, Regulatory Affairs

University of North Carolina at Chapel Hill