Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director, CMC Regulatory Affairs. The position reports to the Senior Director, Regulatory Affairs. The location of the position is in Brisbane, CA and will consider remote option for the right candidate.
The Associate Director, CMC Regulatory Affairs, will provide CMC regulatory expertise and support for development project work. This individual will represent CMC Regulatory Affairs on CMC and Regulatory Submission Teams, create timelines for complete and accurate IND/CTA and NDA/MAA submissions, ensure that clinical trials are designed to meet regulatory requirements, and guide programs to registration submissions.
Essential Duties & Responsibilities
- Collaborate with CMC colleagues to develop global CMC regulatory submission strategies, and maintain global submission timelines to meet business objectives
- Lead RA-CMC due diligence efforts for potential new company assets
- Lead efforts for coordinating CMC content for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications
- Work with the CMC team on plans for NDA/MAA submissions, original or supplements post approval and lead its preparation
- Plan with CMC team and prepare for Regulatory Agency meetings with CMC focus
- Ensure that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements
- Ensure timely escalation of critical issues to senior management by leading regulatory risk assessment, identifying key CMC regulatory issues and mitigation activities needed throughout product life cycle.
- Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions
- Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and background documents for Regulatory Authority meetings
- Prepare, submit, track, index, and archive electronic submissions
- Liaise with Medical Writing personnel for coordinating and publishing submission documents
- Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues
- Perform other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Bachelors or master’s degree in relevant science preferred.
- 10+ years of drug development and regulatory affairs experience in the Biotech/Pharmaceutical industry.
- Demonstrated knowledge of regulatory aspects of small molecule Chemistry, Manufacturing and Controls and quality assurance is a plus.
- Experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development.
- Experience with labeling requirements is a plus.
- Demonstrated management expertise, including leadership and development of employees.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Equal Employment Opportunity