Simplify

Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing & Controls

Simplify

full-time

Posted on:

Location Type: Hybrid

Location: Plymouth Meeting • New Jersey, Pennsylvania • 🇺🇸 United States

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Salary

💰 $125,400 - $213,100 per year

Job Level

JuniorMid-Level

About the role

  • Develop and implement Regulatory Chemistry, Manufacturing & Controls strategies
  • Serve as the CMC Product Lead or support the CMC Product Lead for assigned projects
  • Lead development and execution of global product and project regulatory strategy
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components
  • Provide regulatory leadership as needed to product in-license/due diligence review
  • Collaborate with Organon Manufacturing & Supply colleagues and external partners

Requirements

  • Bachelor’s Degree in science, engineering, or related field
  • At least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree with at least 4 years of relevant experience
  • At least four (4) years of relevant experience
  • Proficient in English; additional language skills are a plus
  • Proven experience in critically reviewing scientific information
  • Demonstrated superior oral and written communication skills
  • Strong listening skills
  • Demonstrated sound understanding of related fields
Benefits
  • retirement savings plan
  • paid vacation and holiday time
  • paid caregiver/parental and medical leave
  • health benefits including medical, prescription drug, dental, and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Regulatory ChemistryManufacturing & ControlsCMC submission componentsbiological researchpharmaceutical researchtestingproject regulatory strategyproduct in-license reviewdue diligence review
Soft skills
oral communicationwritten communicationlistening skillscollaborationleadership
Certifications
Bachelor’s DegreeAdvanced degree
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