Senior Regulatory Affairs Specialist (Remote) (EST/PST Time)

Remote • Posted 2 hours ago • Updated 2 hours ago
Contract W2
12 Months
No Travel Required
Remote
Depends on Experience
Fitment

Dice Job Match Score™

🔗 Matching skills to job...

Job Details

Skills

  • Regulatory Affairs
  • Regulatory Compliance
  • Regulatory Submissions
  • Product Registration
  • Regulatory Documentation
  • Labeling Review
  • Marketing Material Review
  • FDA Regulations
  • Global Regulatory Requirements
  • Regional Regulatory Requirements
  • Pharmaceutical Industry
  • Diagnostics Industry
  • Medical Devices
  • Product Compliance
  • License Renewals
  • Annual Registrations
  • Regulatory Strategy
  • Risk Assessment
  • Risk Mitigation
  • Compliance Management
  • Submission Preparation
  • Regulatory Reporting

Summary

Please note that this is a 12-18 Month Contract position, is Fully Remote and the candidate must work on EST/PST.

JOB DESCRIPTION:

Qualifications:

  • Bachelor''''''''s or master''''''''s Degree or equivalent.
  • Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
  • Typically, at least 4+ years relevant experience for entry into this level.
  • Post-graduate certification and/or license may be required.

Responsibilities:

  • Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
  • Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
  • Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
  • Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
  • Responds to customers’ and/or authorities’ requests/inquiries dealing with regulations and product compliance.
  • Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.

Candidates must provide their phone number. Job reference number is A5387.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: NETSO
  • Position Id: A5387
  • Posted 2 hours ago
Contact the job poster
Manita Tamang

Manita Tamang

Coordinator @ NetSource, Inc.
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Remote

3d ago

Easy Apply

Contract

Depends on Experience

Remote

Today

Easy Apply

Contract

70 - 80

Remote

5d ago

Easy Apply

Third Party, Contract

Depends on Experience

Remote

28d ago

Easy Apply

Contract

34

Search all similar jobs