Senior Director, Commercial Regulatory Affairs

Location
Brisbane, CA, United States
Posted
Feb 02, 2021
Ref
5062633002
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 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 dynamic, highly motivated, experienced individual for the position of Senior Director, Commercial Regulatory Affairs to lead commercial regulatory affairs activities at Myovant as the company prepares to commercialize products for women's health in uterine fibroids and endometriosis. The position reports to the Vice President, Commercial Regulatory Affairs and the location of the position is in Brisbane, California.

POSITION SUMMARY

The Senior Director will provide strategic advice as well as subject matter expertise to cross-functional teams on matters related to the advertising and promotion of pharmaceutical products for women's health in uterine fibroids and endometriosis. He/She will serve as the Regulatory Affairs (RA) representative on assigned labeling and product promotion review teams but not limited to review and approve the regulatory content of US materials created for product promotion, disease awareness, field medical materials, sales training, and corporate communications. The Senior Director will engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials.

ESSENTIAL DUTIES & RESPONSIBILITIES
  • Review US promotional materials, disease awareness communications, field medical materials, sales training materials, and corporate communications by attending the Medical/Legal/Regulatory (MLR) review committee and provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with Myovant policies and FDA regulations pertaining to prescription drug advertising and promotion, as applicable
  • Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Myovant policies
  • Establish regulatory policies to ensure compliance with FDA requirements
  • Serve as the contact for communications with the Office of Prescription Drug Promotion (OPDP) for assigned products
  • Provide training support within Myovant on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
  • Act as advisor to product development teams on advertising and promotion issues to facilitate the strategic development of new products within the Myovant pipeline.
  • Ensure stakeholder awareness of proposed and newly approved labeling changes and FDA guidance documents.
  • Provide strategic guidance to MLR to ensure appropriate implementation for assigned product
  • Develop processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices for the commercial regulatory department to establish standards and consistency across company products
  • Ensure timely submission of all applicable approved promotional materials to the FDA on Form 2253s
  • Coach and mentor junior staff to ensure individual and team success
  • 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
  • At least 15 years in pharmaceutical or biotech industry with at least 8 years in regulatory affairs advertising and promotion, which may include relevant PharmD post-doctoral fellowship experience, and recent launch experience preferred
  • Proficiency in Veeva, Microsoft Word, Excel, PowerPoint, and Adobe Acrobat

CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS
  • Solid knowledge of U.S. FDA advertising and promotional regulations
  • Direct experience communicating and negotiating with OPDP
  • Direct experience leading a recent product launch preferred
  • Experience with FDA standards for advertising and promotion compliance
  • Proven track record practicing sound judgment and MLR advice as it relates to risk Excellent written and interpersonal communication and presentation skills
  • Knowledgeable on industry compliance requirements and enforcement trends
  • Proven ability to prioritize and to manage multiple competing demands to meet critical business timelines
  • Previous people management experience required
  • Ability to influence at all levels and facilitate team/ function to reach effective resolution or decision
  • Thrive at dealing with high level of ambiguity and complexity, highly adaptable to different situations and agile in response, guide/ support the team/ function in time of change
  • Consistently demonstrate a positive, 'can do' and service-oriented attitude

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