Senior Associate, Regulatory Affairs – CMC & Reg. Sciences

OWP Pharmaceuticals

Sr. Associate in Regulatory Affairs at Meitheal Pharmaceuticals handling FDA communications and submissions.

Posted 4/17/2026full-timeChicago • Illinois • 🇺🇸 United StatesSenior💰 $75,000 - $105,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory assessmentsscientific rationalizationchange controlsbiologicsbiochemical engineeringbiotechnologypharmaceutical engineeringstatistical inferencegeometrytrigonometry

Soft Skills

communicationreport writingpresentation skillsanalytical skillsproblem-solvinginterpersonal skillsorganizational skillsrisk managementattention to detailcollaboration