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Regulatory Affairs Specialist - Pharmaceuticals
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Job Location: Saint Louis, MO
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 ofregulatory 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




How To Apply:
You will be directed to another website for application instructions.
 
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