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Job Details

Regulatory Submissions Lead - Biologics

Company: EPM Scientific
Location: Carlsbad
Reference: JEAO2518604
Closing Date: 28 Mar 18
Type: Permanent
Salary (£): 100,000+

Job Summary:

Regulatory Submission Expert required for Global Bio-pharmaceutical CompanyRegulatory Submission Expert | BiologicsGreater San Diego Area$110,000 - $130,000 + excellent bonus + excellent benefits


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.


  • 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


  • 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


Apply for this job: Regulatory Submissions Lead - Biologics

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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