Senior Manager, CMC Global Regulatory Affairs

🕒 June 29

🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 33%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Develop and implement global CMC regulatory strategies for late-stage development, marketing applications, and post-approval lifecycle activities • Plan, prepare, and review CMC sections of regulatory submissions, including IMPD, IND, MAA, NDA, and post-approval variations • Determine regulatory CMC content and scientific/technical requirements for compliant documentation • Lead responses to Health Authority questions and deficiency letters • Represent CMC Regulatory Affairs in project team meetings and provide expert interpretation of regulatory guidelines • Serve as CMC regulatory lead on global project teams across Pharmaceutical Development, Quality, Manufacturing, and Global Regulatory Strategy • Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions • Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations • Monitor and implement regulatory updates affecting marketed products • Represent the company in meetings and negotiations with global Health Authorities on CMC matters • Prepare briefing packages and lead CMC discussions during regulatory interactions • Support departmental initiatives, procedures, process optimization, and efficiency improvements • Develop and maintain collaborative relationships with internal functional units, affiliates, external partners, contract manufacturers, packagers, and suppliers • Use CREDO, PRISM, Trackwise Digital, eCTS Viewer, Adobe Acrobat, and Microsoft Office tools • Perform other duties related to the CMC Regulatory Affairs function

🎯 Requirements

• BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline • 7+ years in Regulatory Affairs CMC, with significant experience in small molecules • Prior experience with biologic, peptide, or oligonucleotide products is ideal • Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead • Regulatory experience handling controlled substance applications is a plus • Comprehensive knowledge of drug development, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP, and related issues • Knowledge of CMC regulatory requirements during late-stage development, initial marketing application, and post-approval • Experience preparing CMC (Quality) sections for IND/IMPD/NDA/MAA/ASMF/CEP and post-approval variation submissions for EMA, UK, CH, US, and Canada • Comprehensive understanding of the global regulatory environment • Strong analytical, problem-solving, organizational, and negotiation skills • Ability to work in a matrix environment and across cultural lines • Strong leadership, communication, and negotiation skills • Ability to manage complex projects and timelines across multiple regions • Demonstrated experience with Microsoft Teams, SharePoint, Word, Excel, and PowerPoint/Outlook • CMC reviewer/assessor experience with EMA, EU, UK regulatory agencies, or FDA is beneficial

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity