Regulatory Affairs Specialist - Pharmaceuticals
Job Opportunity at Surf Search

Posted on Sep 30

http://www.surfsearch.org    858-876.8801

Location: Saint Louis, MO
Job Type: Full Time
Job ID: W4141380

Regulatory Affairs Specialist - Pharmaceuticals

Highly regarded, industry leading pharmaceutical company seeks a Regulatory Affairs Specialist to support worldwide regulatory filings and product registrations.  The Regulatory Affairs Specialist will work with a variety of new drug products.  Requirements for Regulatory Affairs Specialist:
  • Bachelor's degree, preferably in a technical discipline
  • 4+ years regulatory affairs experience in pharmaceutical development
  • RAC certification
  • A depth of experience in preparing, and submitting regulatory filings, both domestically and internationally
  • Strong analytical and technical skills
  • Strong communications skills, oral, written and electronic
  • A strong working knowledge of global regulatory affairs, current guidelines and regulations
The Regulatory Affairs Specialist will:
  • Prepare, submit and maintain regulatory filings with relevant health authorities.
  • Prepare, submit and maintain product specific dossiers per local country requirements
  • Participate in new product development core teams in the creation of regulatory strategies
  • Maintain country specific site registration requirements
  • Assist in preparation of documentation for product incident reporting as required.
  • Review product labeling 
  • Review advertising and promotional material 
  • Utilize and support electronic document management system
  • Respond to inquiries from health authorities.
  • Review and assess regulatory impact associated with changes made at the manufacturing facilities for multiple regions
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