Senior Manager, CMC Global Regulatory Affairs

🕒 June 29

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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 (e.g., MAA/NDA), and post-approval lifecycle activities (extensions/ variations/supplements,) for drug substance, drug products and drug-device combination products • Ensure compliance with global regulations (EMA, FDA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements • Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations) • Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards • Lead responses to Health Authority questions and deficiency letters • Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team • Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, 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 impacting marketed products • Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late stage product development as well as post approval changes • Support departmental initiatives such as preparing/updating departmental job procedures • Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges

🎯 Requirements

• BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline • 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required • 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 in handling-controlled substance applications will be a plus • Comprehensive knowledge of drug development process, 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 • Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND/IMPD/NDA/MAA/ASMF/CEP, post-approval variations) for EMA, UK, CH and equivalent submissions for US and Canada • Comprehensive understanding of the global regulatory environment • Strong analytical, problem solving, organizational and negotiation skills • Strong ability to work in a matrix environment and across cultural lines • Computer skills with demonstrated experience in working with the Microsoft suite of programs (Teams; Sharepoint; Word; Excel; PowerPoint; Outlook)

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs