CMC Regulatory Affairs PM/Submissions Writer

Durham, NC

Posted: 07/08/2022 Job Number: 21048878

Job Description

CMC REGULATORY AFFAIRS PM/SUBMISSIONS WRITER
DURHAM, NC
Required Skills:
  • Scientific and educational background (BSc or MSc) to understand pharmaceutical drug development concepts, regulatory concepts and create documentation based on these concepts .
  • Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance .
  • Excellent project management skills .
  • Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents .
  • Good writing skills for technical writing .
  • Detail oriented and highly organized .
  • Good verbal communication skills for leading meetings and remote interactions .
  • Work well in team setting on a fast-paced business critical project .
  • Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company .

Project Description:
  • Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation .
  • Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders .
  • Assist with ongoing GXP systems transition, related to change control and regulatory dossiers .
  • Ad hoc RACMC support to line manager .
  • Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
  • The outlined tasks may be subject to change as the workload of the business requires .

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02081
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Jim Pizzelanti

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