Leads the CMC function within Global Regulatory Affairs reporting into the Vice President, Global Head of Regulatory Affairs. Provides strategic leadership to support Otsuka's portfolio of investigational and marketed products for local and global filings. The candidate will be responsible for assuring development and execution of regulatory strategies for small molecule, biologic and/or combination products in the US, EU and other territories world-wide. Critical to this role are strong CMC regulatory strategy and leadership skills.
- Provide CMC regulatory affairs leadership, oversight and strategy in support of Otsuka's products, including but not limited to CMC regulatory strategies, regulatory requirements in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
- Provide guidance on the scientific/technical requirements for CMC and GMP related submissions to pending IND/CTAs, BLAs, NDAs and other Life Cycle Management activities.
- Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues as required.
- Review and/or approve CMC and GMP related submission documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use in regulatory submissions.
- Develop and maintain collaborative relationships with Otsuka Japan CMC RA, Factory, Quality, MPDD, partners, Otsuka R&D/Otsuka Europe Tech Ops, other internal groups and contract manufacturers, packagers, suppliers etc.
- Establishes strong cross-functional and divisional partnerships to ensure collaboration with key stakeholders, customers and external organizations.
- Liaise with Global Health Authorities as a responsible Otsuka representative with regards to CMC and GMP issues.
- Provide guidance and supports the team in development of meeting information packages and leads the team in Health Authority CMC meetings.
- Act as global regulatory affairs business unit head with responsibilities to ensure department goals are met, processes are aligned to ensure efficiencies and to promote collaborative global cross-functional relationships.
- Support in-licensing due-diligence activities.
- Analyzes trends and evaluates the impact of changes in Regulatory requirements for CMC related submissions; communicates changes to appropriate areas to ensure compliance with required standards.
- Lead and/or mentor direct reports and/or junior staff members
- Be proficient in the tools and systems needed for the function including and not limited to GEPIC (doc management), ORIOM (regulatory information), Trackwise, Ariba (invoices), Concur (expenses), and Powerpoint
- Be proactive member of teams: Project, Clinical/Regulatory Teams (CRTs), Global Regulatory Teams (GRTs), Submission teams and Lead CMC GRTs, and Submission CMC subteams.
- Performs other duties as assigned.
- In-depth knowledge of global CMC regulations for biologic, small molecule compounds, as well as devices, and the Module 2/ Module 3 eCTD requirements.
- Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP and related issues.
- Highly knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).
- Strong proven hands-on CMC Regulatory Affairs experience and knowledge of CMC regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required.
- Strong understanding of pharmaceutical development, the regulatory environment, project management, and medical terminology.
- Prior supervisory experience
- Have a solution-oriented approach to problem solving
- Ability to work on complex projects and within cross-functional teams with minimal supervision
- Combination product experience desired (Prefilled drug delivery systems, drug/device systems).
- Experience in the biologic and small molecule drug development process and life-cycle activities desired.
- Proactive strategic thinker; Operationally minded (know how to prepare a high quality technical document or submission using internal systems)
- Strong analytical, problem solving, organizational and negotiation skills.
- Strong collaborative inter-personal, communication, presentation and meeting leading 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 (Word, Excel, PowerPoint, and Outlook).
- 15+ years of experience in the pharmaceutical/biotechnology industry, 10 of which are in CMC Regulatory Affairs.
- 8+ years Leadership/management of Regulatory CMC activities and demonstrated organizational/planning skills.
- Bachelors of Science or Bachelors of Arts Degree in a Scientific Discipline; Advanced Degree preferred.
- RAC certification a plus
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
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