Director, CMC Regulatory Affairs
Posted on Apr 5, 2021 by Rakuten Medical
The Director of CMC Regulatory Affairs will be responsible for working with Rakuten Medical development teams to implement global regulatory affairs strategy for assigned company projects with the goal of ensuring appropriate CMC development and standards for IND and commercial stages, device progress and compliance to support approval, BLA readiness for our combination products, and preparation and review of documents for submission to global regulatory agencies. Responsibilities will span pre-IND through post-approval phases of development. This individual may interact with regulatory health authorities in all countries where Rakuten Medical conducts clinical studies and/or intends to market a product. The CMC Regulatory Affairs Director will work closely with other functions of the company, including quality assurance, translational research, CMC, supply chain, regulatory operations, and project management.
Key Duties and Responsibilities
Ensure that corporate policies and clinical programs are aligned with rules and regulations governing the global development of pharmaceuticals
Develop and implement strategies for the earliest possible approval of regulatory applications
Manage regulatory consultants as needed
Oversee assigned projects, and coordinate other assigned resources
Participate in product strategy teams to provide advice and direction, including identifying and assessing regulatory risks regarding global regulatory requirements and strategies
Work closely with development teams to write, review, and revise documents for submission to global regulatory health authorities to ensure
Appropriate planning, review, and tracking of all regulatory submission documents
Acceptability of data, procedures, and other documentation presented in support of clinical trials through submission of marketing application(s)
Regulatory arguments are presented clearly and conclusions are supported by data and their associated risk assessments
Appropriate reporting of safety and device deficiencies
Document publishing, QC, and submission occurs in a timely fashion
Interact and communicate with regulatory health authorities as assigned
Perform regulatory intelligence activities to stay current on the global regulatory environment and competitive products; communicate such environment to the teams
Participate in the development of Regulatory Affairs department SOPs
Work with regulatory and quality teams to ensure compliance with the global regulatory health authority regulations and interpretations and to design and implement training on regulatory issues for staff and for business stakeholders
Other duties as assigned
Desired Education, Skills and Experience
Bachelor's and Master's or Ph.D. degree in scientific, health care, or related field or equivalent.
A minimum of 7 years of pharmaceutical industry experience
5+ years of regulatory experience
Experience in a strategic leadership capacity
Must demonstrate understanding of drug development and knowledge of FDA requirements
Direct experience with FDA required and international experience preferred
Device and/or combination product experience preferred
Highly organized with attention to detail.
Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
Working knowledge of electronic publishing/file management system.
Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications.
Exceptional self-management ability
Travel as needed for interactions with Regulatory Health Authorities