OWP Pharmaceuticals

Senior Associate, Regulatory Affairs – CMC & Reg. Sciences

OWP Pharmaceuticals

full-time

Posted on:

Location Type: Hybrid

Location: Chicago • Illinois • United States

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Salary

💰 $75,000 - $105,000 per year

Job Level

Senior

About the role

  • Support, prepare, and review communication documents & submissions to the agencies, including controlled correspondences, FDA meeting packages (Pre-ANDA, Pre-IND, BIA, BPD2/3/4, etc.), and submissions (IND, NDAs, ANDAs, BLA)
  • Address complex and technical issues with solid scientific rationalization, with or without supervision
  • Identify and act on issues and risks from regulatory perspective, especially for complex generics and biosimilars
  • Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines
  • Track deficiency trends and develop proactive and/or mitigation measures accordingly

Requirements

  • Bachelor’s or master’s degree in life sciences
  • 2+ years relevant industry experience in the areas of research and development, or regulatory
  • Background and experience in biologics or biochemical engineering/biotechnology, pharmaceutical engineering are highly preferred
  • Ability to write reports, business correspondence, and procedure manuals
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Proficiency in Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge)
Benefits
  • Competitive pay and medical, dental, and vision insurance
  • Flexible spending accounts
  • Long- and short-term disability insurance, as well as life insurance
  • 401(k) plan with employer contribution
  • Competitive PTO and company-paid holidays
  • Paid parental leave (maternity & paternity)
  • Onsite gym
  • Hybrid work schedule
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory assessmentsscientific rationalizationchange controlsbiologicsbiochemical engineeringbiotechnologypharmaceutical engineeringstatistical inferencegeometrytrigonometry
Soft Skills
communicationreport writingpresentation skillsanalytical skillsproblem-solvinginterpersonal skillsorganizational skillsrisk managementattention to detailcollaboration