Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Regulatory Affairs- Women's Health. The position reports to the Vice President, Regulatory Affairs. The location of the position is in Brisbane, CA.
The Director of Clinical Regulatory Affairs - Women's Health will provide leadership on global regulatory activities for Myovant. Responsibility includes nonclinical, clinical and CMC regulatory filings and providing strategic as well as operational leadership on the project teams in these areas. The candidate will develop regulatory strategies and manage IND and NDA submissions, FDA and other regulatory interactions, as well as international submissions, for the product candidates. 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
- Develop regulatory strategic plans in conjunction with project teams and assist in the design of nonclinical and clinical study programs required for regulatory approval.
- Responsible for filing of IND/CTA/NDA/MAA submissions. Set strategy for submissions of product registration documents to health authorities worldwide.
- Interacts 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.
- Represent Myovant before regulatory authorities on designated programs.
- Work with project teams to resolve complex project issues.
- Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
- Effectively plan, organize, and conduct in close collaboration with leads from other functional areas formal meetings with regulatory agencies.
- 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.
- Assure compliance with project team timelines and milestones.
- Provide organizational support and be prepared to manage personnel as company grows its product development pipeline
- Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- 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 demonstrates 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.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Advanced degree MD, PharmD, or PhD preferred
- 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs and have successfully filed IND and NDA/MAA submissions
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Approximately 10% travel
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