Clinical Regulatory Affairs Manager

Location
Brisbane, CA, United States
Posted
Jul 05, 2021
Ref
5182075002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.

Summary Description

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Clinical Regulatory Affairs Manager located at our Brisbane office. The Manager of Clinical Regulatory Affairs will be responsible for developing and implementing global regulatory strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory aspects of compounds through all phases of development, post-approval, and the life cycle of the product depending on assigned products. Primary responsibilities include developing and implementing global regulatory strategies with managerial oversight, independently maintaining open applications (INDs, NDAs, CTAs, MAAs) with routine submissions and with managerial oversight on complex submissions and working closely with cross-functional stakeholders to support preparation and maintenance of regulatory applications for development and commercial product programs.

Essential Duties and Responsibilities
  • Partner with global regulatory leader on developing and implementing the global regulatory strategy for the assigned early and late stage projects. Lead some aspects of strategy and support others depending on complexity.
  • Prepare integrated plans relating to regulatory submissions. Manage/Assist with the coordination, preparation, review and submission of high quality and timely documentation to support investigational and marketing registration packages including the review of protocols, CSRs, IND/CTAs, NDA/MAAs, and other global submission documents in conformance with regulatory requirements and strategies.
  • Review sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with regulatory requirements and strategies while ensuring high quality and timely submissions.
  • Lead the preparation of responses to questions from authorities.
  • Provide operational regulatory support on assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, risk assessments, critical issue management and advice on Health Authority interactions.
  • Interact with FDA and other global regulatory authorities for assigned project under supervision to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, CTAs and other submissions. Prepare project teams for FDA and other regulatory health agency meetings, as required.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulatory agency regulations and guidelines, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
  • Participate in and/or otherwise lead other special projects and initiatives.
  • Business travel to be ~10-20% as required

Core Competencies
  • Strong working knowledge of drug development process and scientific and regulatory environment in pertinent therapeutic areas
  • Proven ability to research current and historical regulatory environment and assess its impact on assigned products.
  • Previous experience with major submissions such IND/CTAs, NDA/BLA/MAAs, or upplements/variations
  • 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

REQUIREMENTS (Education and Experience)
  • Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
  • Minimum 5+ years of relevant experience in biotech or pharmaceutical industry in a regulatory affairs position or related area

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.

If you require any accommodations, please email careers@myovant.com.

Equal Employment Opportunity