Senior Manager, Regulatory Affairs – CMC, Reg. Sciences
OWP Pharmaceuticals
full-time
Posted on:
Location Type: Hybrid
Location: Chicago • Illinois • United States
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Salary
💰 $120,000 - $155,000 per year
Job Level
About the role
- 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
- 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
- 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 guidanceproduct developmentCMCIND submissionsBIABPD2/4BLAsbiologicsbiosimilarsstatistical inference
Soft Skills
communicationpresentationproblem-solvinganalytical skillstrainingcollaborationinterpretationwritingorganizational skillsmathematical skills