Senior Director, Head of CMC, Global Regulatory Affairs
Company: Otsuka Pharmaceutical
Posted on: June 25, 2022
Job SummaryLeads 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.Job Description
- 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
- 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
- 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
- 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
- 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
- Lead and/or mentor direct reports and/or junior staff
- 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.Knowledge/Experience/Skills
- 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
- Prior supervisory experience
- Have a solution-oriented approach to problem solving
- Ability to work on complex projects and within cross-functional
teams with minimal supervisionPreferred Knowledge
- 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.Skills
- Proactive strategic thinker; Operationally minded (know how to
prepare a high quality technical document or submission using
- Strong analytical, problem solving, organizational and
- Strong collaborative inter-personal, communication,
presentation and meeting leading skills.
- Strong ability to work in a matrix environment and across
- Computer skills with demonstrated experience in working with
the Microsoft suite of programs (Word, Excel, PowerPoint, and
- 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.Educational
- Bachelors of Science or Bachelors of Arts Degree in a
Scientific Discipline;-- Advanced Degree preferred.
- RAC certification a plus#LI-Remote
Keywords: Otsuka Pharmaceutical, Trenton , Senior Director, Head of CMC, Global Regulatory Affairs, Executive , Princeton, New Jersey
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