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Regulatory CMC Manager- Multinational Company



Business Type: Contract Research Organisation
Job Type: Regulatory Affairs
Job Level: Management
Position: Full Time
Location: USA - California
Reference: 293252.4
Closing Date: 28/07/21
Job Details:

Our client is a worldwide company in need of an autonomous Manager of CMC Regulatory Affairs to plan, execute and manage regulatory submissions for all phases of the drug development life cycle including clinical development, global marketing applications, and post-approval life cycle activities.

The position is fully remote and can be worked across the United States.

Other key responsibilities include:

  • Independently define CMC content requirements for regulatory submissions
  • Ensure and/or enhance regulatory compliance with respect to filing requirements
  • Evaluate change proposals
  • Liaise with other regulatory and health bodies

Requirements:

  • 5 years+ relevant experience
  • Bachelor''s or Master''s degree in a relevant field of study
  • Advanced knowledge of regulatory CMC requirements for global drug development and post-market support initiatives
  • Excellent presentation skills
  • Ability to provide strategic regulatory guidance to various support teams

If this sounds like you, send your resume/CV to g.lafebre@nonstopconsulting.com

NonStop is one of the largest and fastest-growing specialized life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labor leasing licenses across Europe. Please visit our website for a full list of the niche markets we cover



NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 21/07/2021 | NPJ Ref: 276013
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