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Regulatory Senior Manager

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $140000 - $150000 per annum
  • Job reference: MLSN120117920
  • Sector: EPM Scientific, Regulatory
  • Date posted: 01/12/2017

A leading research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need is looking for a Regulatory Manager/Senior Manager to join their actively growing team.

Position Summary:

Responsible for supporting the Regulatory department across a number of company-sponsored projects. Primarily responsible for assembling and reviewing regulatory dossiers prior to review by senior regulatory management. May select, develop, and evaluate personnel to ensure the efficient operation of the function.

Responsibilities:
  • Prepares information for, review and ensures that submissions meet format and content requirements applicable for regulatory requirements (i.e., US, ICH).
  • Reviews specifications, methods, SOPs, protocols, reports, labeling, and etc..for regulatory compliance.
  • Maintain regulatory submissions and correspondence for company-sponsored projects, and all company-related sections for partner-sponsored projects.
  • Drafts and reviews Regulatory Affairs' SOPs.
  • May participate in, and provide regulatory guidance to working teams (both internal and partnered programs).
  • Capable of working independently to complete mid-level assigned projects.

Requirements:
  • A minimum of a Bachelors degree in a scientific discipline is required.
  • Minimum of 4 years hands-on Regulatory Affairs experience, in either drugs and/or medical devices is required.
  • Experience in working in a multi-disciplinary team environment is preferred.
  • Ability to adapt to changing priorities and to manage multiple tasks is required.
  • Strong computer skills in Word, Excel and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset.
 

If you are interested, please apply below!

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