Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager, Regulatory Operations. The position reports to the Director, Regulatory Operations. The location of the position is in Brisbane, CA.
The Regulatory Operations Senior Manager supports a variety of activities in the Regulatory Affairs department related to regulatory operations and systems. The individual must have the ability to work independently, and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
- Oversight of Myovant’s Regulatory Information Management platform including file transfer, storage, tracking, and archival of Regulatory submission documents.
- Prepare high-quality global regulatory dossiers (electronic) according to health agency requirements and guidance for either drugs, biologics and/or gene therapy product(s);
- Provide oversight and support the processing of Myovant’s Regulatory records within the company archive.
- Independently, serve as Regulatory Operations Lead for identified submission projects (including Marketing Applications). Provide guidance and partner with project teams (Regulatory Affairs and contributing business functions) supporting effective submission planning, building and dossier delivery activities;
- Review of regulatory documents and published dossier for technical completeness and compliance with health agency requirements;
- Manage various systems and tools within Regulatory (including, but not limited to, Publishing, eCTD Viewer, Authoring Templates, Regulatory Archive, Product Registration, Electronic Gateway);
- Contribute, and provide oversight to the maintenance of system documentation throughout the lifecycle of regulatory systems;
- Assess impact of regulatory changes to current work procedures, including in ex-US regions and provide necessary guidance to team;
- Lead and/or coordinate the development or update of regulatory processes (SOPs, Work Instructions and/or Internal Guidelines) for submission preparation (electronic or paper), support QC, and regulatory information management;
- Support in-house training to ensure optimal use of templates, processes and tools critical for submission documents and information management; and
- Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.
- Represent Regulatory Operations in cross-functional meetings with Regulatory Affairs, Customer Service, Marketing, Supply Chain, Quality, Manufacturing Operations and Information Technology (IT). This may include Senior Leadership updates.
- Actively mentor and provide guidance and direction to support development of team peers.
Core Competencies, Knowledge and Skill Requirements
- Extensive knowledge and experience with Microsoft Office Suite, Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems
- Advanced understanding of relevant health agency requirements, submission standards, software validation concepts, and publishing best practices.
- Strong time management and organization skills
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstration of a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- BS/ BA in a relevant scientific discipline is preferred
- 7 years of industry experience working in pharmaceutical drug development; previous experience in Regulatory Operations is required.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
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.
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Equal Employment Opportunity