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Regulatory Submissions Lead - Biologics

  • Job type: Permanent
  • Location: Carlsbad
  • Salary: £110000 - £130000 per annum
  • Job reference: JEAO2518604
  • Sector: EPM Scientific, Regulatory
  • Date posted: 14/03/2018
Regulatory Submission Expert required for Global Bio-pharmaceutical Company
  • Regulatory Submission Expert | Biologics
  • Greater San Diego Area
  • $110,000 - $130,000 + excellent bonus + excellent benefits
A global Bio-Pharmaceutical Company, with over 300,000 products on the market and 600 locations worldwide, is currently seeking to speak with an experienced Regulatory liaison to support their client’s regulatory needs for compliance.

The successful incumbent will exhibit a strong understanding of regulations relevant to the biopharmaceutical space (materials, processing, etc...). The ideal candidate will be knowledgeable of regulatory developments in the market, and leverage that knowledge, to apply the appropriate regulatory strategy for biological drug cGMPs.

Responsibilities:
  • Responsible for regulatory submission activities related to biopharmaceutical ingredients
  • Coordinate listing activities for BLA submissions of biological materials
  • Participate in product development process to develop and execute regulatory strategies/plans
  • Support clients for NDA/BLA and IND supplements as required
  • Review and prepare documents for submission to Regulatory Agencies
 Qualifications:
  • BS or higher in life sciences (Chemistry, Biology)
  • Minimum 5 years industry/regulatory affairs experience
  • Knowledgeable of US FDA and EU drug regulations specifically for BLA submissions for biological drug products
 


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