Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Default2

Regulatory Affairs CMC Manager

Alpha Consulting Corp. Irvine Contractor
Apply Now
REGULATORY AFFAIRS CMC MANAGER
IRVINE, CA
 
 
Project Description:
This position will execute CMC projects within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of biologics and device/biologics combination products. 
  • Execute and manage the implementation of Regulatory CMC strategy. 
  • Management of regulatory assessments and notifications with change control system. 
  • Functions as primary contact for CMC issues with regulatory authorities for assigned products and projects. Prepares and issues Regulatory Agency Telephone Contact Reports and Meeting Minutes. 
  • Actively participate in project team meetings and provide leadership in meeting submission goals. 
  • Determines nature, scope and format of CMC information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; and obtain and maintain market approval for development and approved products. 
  • Manages response team for regulatory agency CMC inquiries. 
  • Administers preparation of briefing and presentation materials for Regulatory Agency meetings. 
  • Represents Regulatory Affairs CMC on project teams for assigned products/projects. 
 
Required Skills:
  • B.S. required in related scientific discipline with a minimum of 2+ years of regulatory CMC experience and 4+ years of pharmaceutical, biologics or related, experience.
  • Regulatory environment, regulatory submission and/or pharmaceutical healthcare environment. 
  • Business and personal computer hardware and software applications. 
  • Excellent written and verbal communication, presentation, and facilitation skills 
  • Collaborate with management to develop appropriate regulatory strategy. 
  • Interpret global regulations and apply Health Authority guidance to the development of CMC regulatory documentation. 
  • Establish strong working relationships within the project teams by proactively managing global CMC strategies, submissions, and timelines. 
  • Work independently to prioritize and manage multiple projects and assignments. 
  • Ability to build bridges between diverse groups of stakeholders. 
  • Pharmaceutical manufacturing facility/development laboratory preferred. 
  • Experience in the preparation and management of regulatory submissions including experience in preparation of responses to issues raised by global Health Authorities. 
  • Global registration support. 
  • Perform regulatory assessments in a cGMP change control environment. 
  • Sound basis of Scientific (Training/Communications) knowledge in multiple areas. 
  • Demonstrated ability to prepare and manage ensure thoroughness, and accuracy of global CMC dossiers. 
  • Ability to handle multiple assignments and prioritize work independently. 
  • Experience with biologics products. 
 
This 10+month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: URL blocked - click to apply
 
ALPHA'S REQUIREMENT #19-01641
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
 

Recommended skills

Pharmaceuticals
Manufacturing
Health Care
Leadership
Presentations
Communication
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 19-01641

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.