Senior Manager, Regulatory Affairs – CMC, Reg. Sciences

OWP Pharmaceuticals

Senior Manager, Regulatory Affairs overseeing regulatory guidance for product development at Meitheal Pharmaceuticals. Managing submissions and regulatory compliance for biopharmaceuticals.

Posted 4/17/2026full-timeChicago • Illinois • 🇺🇸 United StatesSenior💰 $120,000 - $155,000 per yearWebsite

About the role

Key responsibilities & impact

Provide regulatory guidance to product development
Support and review CMC sessions in submissions & deficiency responses
Manage the regulatory aspects of products and projects
Prepare and review communication documents & submissions to the agencies, including IND, BIA, BPD2/4, BLAs, etc.
Track and interpret FDA new guidance & new requirements and assess their impact on product development
Represent the regulatory function on cross-functional developmental teams primarily with Operation, Quality, Legal and Marketing groups
Provide training on regulatory sciences within RA department and cross-functions

Requirements

What you’ll need

Master’s or Ph.D. degree in life sciences
Over 5 years related experience in product development and/or regulatory CMC or equivalent combination of education and experience
Expertise in and experience with complex /combination generics (peptides), biologics and/or biosimilars are highly preferred
Ability to author 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 apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
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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Hard Skills & Tools

regulatory guidanceproduct developmentCMCIND submissionsBIABPD2/4BLAsbiologicsbiosimilarsstatistical inference

Soft Skills

communicationpresentationproblem-solvinganalytical skillstrainingcollaborationinterpretationwritingorganizational skillsmathematical skills