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Senior Manager Regulatory Affairs

Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

8-10 years of relevant experience, Fluency in English.

Key responsabilities:

  • Implement CFDA registration projects
  • Develop strategies for product line and DMFs/Drug Product applications
  • Support decision-making on DMFs and drug development
  • Collaborate with stakeholders to address timely issues and ensure Regulatory compliance
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Workforce Solutions Virēns Global “ WFS “ Hrtech: Human Resources + Technology Startup https://virenssolutions.com/
11 - 50 Employees
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Job description

Senior Manager Regulatory Affair

A well-known large healthcare company is hiring for Senior Manager Regulatory Affairs to implement CFDA registration projects, make strategy for product line and DMFs and Drug Product applications.. Responsibilities include:

  • Technically and strategically support decision making on DMFs & drug development
    • Compile filing data to obtain CFDA certificates /approvals
    • Work with stakeholders for follow up and resolution of timely issues
    • Ensure enhancing Regulatory compliance throughout development and the commercial life cycle
    • Manage other stuff like promotional materials review, standard compiling, product labeling, local-test designs, data analysis

    Requirements

    • Atleast 8-10 years relevant experience
      • Fluency in English

      If you are interested in the above opportunity please apply. Only relevant candidates will be contacted.

      workforcesolutionsvirensglobal... Locations: America, Europe, Asia & Australia

      Required profile

      Experience

      Level of experience: Senior (5-10 years)
      Spoken language(s):
      English
      Check out the description to know which languages are mandatory.

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