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Manager, Global Regulatory Affairs in Boston, MA at Atrium Staffing

Date Posted: 12/9/2018

Job Snapshot

  • Employee Type:
  • Location:
    Boston, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Our client is a global specialty biopharmaceutical company, with a huge line of products and brands. They are currently looking for Manager, Global Regulatory Affairs to join their office.

Salary/Hourly Rate:
Competitive with market rate

Position Overview:
 The position includes management of regulatory affairs activities for developing global strategies across product life cycles & execution in North America.

Responsibilities of the Manager, Global Regulatory Affairs: 

  • Provide collaborative support for execution of global strategies to other regions (EU & International)  
  • Provide support to other HA interactions as required
  • Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs 
  • Manage product development and make sure manufacture is in compliance with appropriate regulations and guidelines so that they can be studied and marketed as planned
  • Manage preparation of US and Canada applications in a timely manner to meet corporate objectives
  • Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives

Qualifications for the Manager, Global Regulatory Affairs: 

  • Minimum of 4 years experience in pharmaceutical product development including significant experience regulatory affairs with a strong biologics background or equivalent
  • Experience in directing interactions with regulatory authorities desired. Knowledgeable in ICH and FDA guidelines

Education Requirements: 

  • B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field

BenefitsEligible for Atrium Care Package

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