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Senior Director, Clinical Regulatory Affairs

Employer
Myovant Sciences
Location
Brisbane, CA
Start date
Sep 16, 2022

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Discipline
Clinical, Clinical Research, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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 leader for the position of Senior Director, Clinical Regulatory Affairs who will provide regulatory strategic and operational leadership to advance the development and approval of Myovant’s Women’s Health pipeline. The individual will develop regulatory strategies for assigned programs, manage submissions to global health authorities, and lead global regulatory agency interactions. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. This position reports to the Vice President, Clinical Regulatory Affairs.  The location can be flexible for the right candidate. 


Essential Duties and Responsibilities

  • Develop global regulatory strategies for assigned programs and plans for execution in conjunction with leads from other functional areas and project teams
  • Set strategy and required content of scientifically sound, accurate and complete nonclinical and clinical submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.)
  • Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions
  • Provide interpretation of regulatory authorities’ feedback, policies and guidelines to Myovant personnel and serve as a liaison between Myovant and regulatory authorities
  • Work with project teams to resolve complex project issues
  • Provide regulatory guidance to project teams including identifying and assessing regulatory risks for non-clinical, clinical, and commercial development plans and activities
  • Effectively plan, organize, and conduct formal meetings with regulatory agencies in close collaboration with leads from other functional areas
  • Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications
  • Responsible for the creation, updating, and maintenance of the company core data sheet and local labelling records throughout product lifecycle, ensuring compliance with regulatory authority requirements
  • Assure compliance with project team timelines and milestones
  • Serve as the Chair of the Regulatory Strategy Team for assigned programs
  • Serve as the regulatory representative on the Product Development Team for assigned programs
  • Manage and mentor regulatory personnel and provide leadership for junior regulatory staff
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures

Core Competencies

  •  Demonstrate communication and collaboration skills with an ability to effectively manage and influence stakeholders in a matrix environment
  • 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
  • Demonstrate coaching skill to inspire, develop, and motivate team

REQUIREMENTS (Education and Experience)

  • Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
  • Advanced degree MD, PharmD, or PhD preferred along with 15 years of biopharmaceutical experience, which include at least 12 years of direct experience in Regulatory Affairs
  • Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs)
  • Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional)
  • Demonstrated experience with managing, training and developing employees
  • Proven leadership skills and ability to collaborate and work effectively in teams across different businesses, functions, and geographies

The well-being and safety of our employees is our top priority.  Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based).  Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered.  If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

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

Company

We aspire to be the leading healthcare company focused on redefining care for women’s health and prostate cancer. Our experienced team brings significant breadth and depth of expertise in drug development, combined with a commitment to develop new treatments for women suffering from uterine fibroids, endometriosis, and infertility, and men suffering from prostate cancer. We strive to improve the lives of millions of people, while building an innovative, dynamic, and collaborative company where employees thrive.

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Find Us
Website
Phone
650-392-0222
Location
2000 Sierra Point Parkway, Suite 900
Brisbane, CA 94005
United States
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