Senior Associate, Regulatory Affairs – CMC

OWP Pharmaceuticals

Senior Regulatory Affairs Associate responsible for regulatory submissions and compliance in the pharmaceutical industry. Managing multiple projects and interfacing with the FDA and internal teams in hybrid work environment.

Posted 6/5/2026full-timeChicago • Illinois • 🇺🇸 United StatesSenior💰 $70,000 - $85,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for on-time filing of high-quality regulatory submissions
Preparation and review of ANDAs, NDAs, annual reports, periodic adverse events reports, supplements, amendments
Reviews and manages regulatory submissions to FDA from international partners and CMOs
Review and approve CMC and Labeling change controls
Familiar with FDA requirements and ICH
Adhere to submission timelines
Administration and management of assigned products
Serve as the primary regulatory interface with US FDA manufacturing partners and internal teams
Support Biosimilar BLA/PAS/CBE submissions

Requirements

What you’ll need

Bachelor’s degree in life sciences preferred, or equivalent experience required
5 or more years of recent pharma / biotech / life sciences industry experience in a related function (Regulatory Affairs, R&D, Quality, Manufacturing) preferred
Strong written and communication skills
Ability to handle multiple projects concurrently
Familiar with 21 CFR, FDA and ICH
MS Office proficiency (Excel, Word, PowerPoint)

Benefits

Comp & perks

Competitive pay
Medical, dental, and vision insurance
Flexible spending accounts
Long- and short-term disability insurance
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 submissionsANDA preparationNDA preparationadverse events reportingCMC change controlsLabeling change controlsBiosimilar BLA submissionsBiosimilar PAS submissionsBiosimilar CBE submissionsFDA requirements

Soft Skills

strong written communicationstrong communication skillsproject managementability to handle multiple projects