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CMC Regulatory Affairs

CMC Regulatory Affairs

Requisition ID 
2016-8345
Job Locations 
US-NJ-Princeton

Opportunity Details

Overview

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.   

 

OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

 

Responsibilities

Provide CMC regulatory expertise for investigational and marketed products to project teams. Establish CMC regulatory strategies for investigational and marketed products. Ensure Otsuka’s products are developed in compliance with global regulatory requirements and guidances primarily US and secondarily EU for smooth and timely approvals. Ensure Otsuka’s marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.

 

Additional Responsibilities Include: 

  • Anticipate, develop and recommend strategies and contingency plans, provide guidance, determine regulatory and scientific/technical requirements for CMC and GMP related submissions and enquiries for drugs, devices and drug-device combinations from the health authorities. .
  • Prepare and/or review all CMC and GMP related documents/labels and labeling for submission to regulatory authorities to assure compliance with regulatory standards and scientific/technical requirements and ensure the proper preparation and approval of these submissions
  • Develop and maintain collaborative relationships with OPCJ CMC RA, Factory, Quality, MPDD, partners, OPDC/OPEL Tech Ops, other internal groups and contract manufacturers, packagers, suppliers etc.
  • Represent Otsuka at regulatory authority CMC meetings. Lead interactions and negotiations with regulatory authorities on CMC and GMP issues for products.
  • Monitor, interpret, and provide guidance on current developments in guidances, regulations, practices and policies in CMC and GMP areas.
  • Provide regulatory assessment and input on Change Controls, review supporting data and reports and update in computer systems as needed. Also support in-licensing due diligence activities.  
  • Ensure preparation and approval of CPPs in support of Otsuka affiliates and Partners
  • Be proficient in the tools and systems needed for the function including and not limited to GEPIC (doc management), ORIOM (regulatory information), Trackwise, Accelim (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.

Qualifications

Knowledge

  • Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
  • Thorough knowledge of FD&C Act, 21 CFR, FDA and ICH Guidances, FDA policies and practices for drugs, devices and drug-device combinations. Similar knowledge of EMA, Latin America and middle-east countries will be a plus
  • Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe
  • Comprehensive understanding of the global regulatory environment.

 

Skills

  • 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 matrixed environment and across cultural lines.
  • Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,
  • Excel, PowerPoint, and Outlook).

 

Education

Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics or Industrial Pharmacy and minor in Medicinal Chemistry or vice-versa

Experience:

  • 3-5 years – Manager;  5-7 years - Sr. Manager;  7-9 Assoc. Dir.; 9 or more years of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead
  • 3 - 5 years of hands-on pharmaceutical product development, including scale-up and technology transfer to manufacturing and/or manufacturing experience is highly desirable. 
  • As a CMC reviewer (assessor) with FDA or EMA is highly desirable:

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