CMC Regulatory Affairs Manager - Remote Option

  • Location
    Chicago , Illinois
  • Category
    Medical & Science - Regulatory
  • Job type
    Direct Hire

A CMC Regulatory Affairs Manager in Chicago IL is available courtesy of Adecco Medical and Science. In this role, they are looking for someone to prepare, compile, and review regulatory dossiers (INDs, NDAs, annual reports). Work with manufacturing partners to facilitate contract manufacturing operations. The individual will work closely with third party vendors in various sites worldwide to support ex-US regulatory applications and operations. In addition, the individual should have a strong quality background and have performed audits of contract manufacturers, with an emphasis on sterile products. For the right candidate, the position could be primarily home office based but you would be required to make a few trips per year to Nashville to familiarize with files, documents, projects, etc. This is a direct-hire role starting immediately.


The CMC Regulatory Affairs Manager in Chicago, IL job responsibilities include:


Responsibilities

Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include Agency Meeting Packages, INDs, NDAs, ANDAs, amendments and supplements, responses to requests for information, etc. Hands-on participation in submission preparation is expected.
Reviews technical reports and summary documents (chemistry, manufacturing and quality) for adherence to regulatory guidelines, strategies, and commitments
Liaise with contract manufacturing partners.
Review technical documentation including but not limited to stability protocols, specifications, batch records, technical reports and change controls and recommend changes as appropriate to ensure compliance and conformances with existing regulatory applications and approval.
Review batch documents from CMOs and perform batch release.
Perform quality assurance audits of 3rd party vendors.
Serve as the CMC regulatory representative on internal and external product teams.
Provide regulatory subject matter expert advice to the quality assurance function as needed.


Requirements/Qualifications:

BS in bio/chemistry, microbiology, pharmacy or related engineering subjects.
10+ years of relevant experience in pharma/biopharma.
Experience with parenteral products.
Previous experience with pharmaceutical CMC filings for INDs and NDAs.
FDA, ICH and other relevant CMC/Quality and cGMP guidance documents.
Writing regulatory and scientific documents.
General regulatory and scientific knowledge of drug development.
Experienced performing Quality Assurance audits.


If you are interested in this CMC Regulatory Affairs Manager job opportunity in Chicago, IL then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled


  • Apply with Adecco

Reference number US_EN_2_102814_320038