CMC Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Location: Remote

Duration: 12 months

Role Description

Provide CMC regulatory strategy input and expertise in investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidance. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.

Position Responsibilities Include

• Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products.
• Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.
• -Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s).
• Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
• Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
• Provide regulatory assessment in change management.
• Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc..
• Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings.
• Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
• Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Track wise, Concur (expenses), and PowerPoint.
• Performs other duties as assigned.
  
  

Qualifications

Knowledge:

• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
• 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 and Canada
• Comprehensive understanding of the global regulatory environment.
  
  

Education

• Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., master’s and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology
• RAC certification a plus
  
  

Experience

• 5 to 7 years or more 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.
• Regulatory experience in handling-controlled substance applications will be a plus.