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 currently seeking a dynamic, highly motivated, experienced individual for the position of Senior Manager / Associate Director, Commercial Regulatory Affairs to support commercial regulatory affairs activities at Myovant as the company grows their prostate cancer business. The position reports to the Senior Director, Commercial Regulatory Affairs and the location of the position is in Brisbane, California or can be remote.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Represent Myovant Commercial Regulatory for the review of US promotional materials, disease awareness communications, sales training materials, corporate communications, and other materials as assigned, by attending the Medical/Legal/Regulatory (MLR) review committee.
- Thoroughly review and assess assigned draft branded and unbranded materials to evaluate their completeness, accuracy, and compliance with regulatory requirements and Myovant policies.
- Help ensure MLR comments are incorporated with completeness and in the spirit of MLR reviewers’ guidance given.
- Support timely submission of all applicable promotional materials to the FDA for Advisory Comment or on Form 2253
- Help ensure appropriate implementation/execution for approved materials.
- Help the Commercial Regulatory department develop processes and procedures relevant to the creation, review, and approval of advertising and promotional materials that are aligned to and consistent with establish standards across company products.
- Gain familiarity and stay updated with the latest FDA enforcement activities and changes in the regulatory environment.
- Participate in professional associations and training meetings related to advertising and promotion regulatory requirements and relevant medical congresses within assigned therapeutic areas.
- Other duties as assigned
EDUCATION, EXPERIENCE AND QUALIFICATIONS
Required
- BS or BA degree required in life sciences in a relevant discipline. Advance degree MA/MS, PharmD, or PhD preferred
- Minimum 10 years in pharmaceutical or biotech industry with at least 4 years in regulatory affairs, which may include relevant PharmD post-doctoral fellowship experience, and recent launch experience preferred.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. Experience in VeevaVault preferred.
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 decisions that are 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
- Experience in working with detailed operational procedures and validated environments.
- Working knowledge of U.S. FDA advertising and promotional regulations
- Working knowledge of FDA standards for advertising and promotion compliance
- Generally knowledgeable of industry compliance requirements and enforcement trends
- Ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines
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