The Director of Regulatory Affairs will be responsible for working with Rakuten Aspyrian development teams to implement global regulatory affairs strategy for assigned company projects with the goal of ensuring timely clinical study execution, CMC development, and BLA readiness for our biologic/drug combination therapies. Responsibilities will span pre-IND through post-approval phases of development. This individual will interact with regulatory health authorities in all countries where Rakuten Aspyrian conducts clinical studies and/or intends to market a product. The Regulatory Affairs Director will work closely with other functions of the company, including quality assurance, clinical affairs, clinical development, pharmacovigilance, medical affairs, CMC, 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
- Advise and manage regulatory consultants
- Oversee ongoing projects from a Regulatory perspective.
- 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 regulatory health authorities (US, EU, Asia, Canada) 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
- Document publishing, QC, and submission occurs in a timely fashion
- Interact and communicate with regulatory health authorities in countries where Rakuten Aspyrian is conducting clinical trials or plans to market product
- Perform regulatory intelligence activities to keep 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, healthcare, 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 an 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
Location: San Diego or San Mateo, California
Min. Experience: Senior Level