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Otsuka Pharmaceutical Companies (U.S.) · 2 weeks ago

Senior Manager, CMC Global Regulatory Affairs

United States

Full-time

Remote

Senior Level

$147K/yr - $220K/yr

7+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager for their CMC Global Regulatory Affairs team. The professional will be responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle, ensuring compliance with global regulations and leading cross-functional project teams.

Health CareMedical

Comp. & Benefits

Responsibilities

Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products

Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements

Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements)

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

Represent the company in meetings and negotiations with global Health Authorities for CMC related matters

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

Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus

Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc

Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools

Performs other duties as assigned related to CMC RA function

Qualification

CMC regulatory strategiesRegulatory submissionsDrug development processGlobal regulatory environmentRAC certificationSmall moleculesProject managementAnalytical skillsMicrosoft Office proficiencyBiologicsLeadership skillsNegotiation skills

Required

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

Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues

Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval

Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe 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

Strong leadership, communication, and negotiation skills

Ability to manage complex projects and timelines across multiple regions

Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)