Director, Regulatory Affairs, CMC
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. The position reports to the Senior Director, Regulatory Affairs. The location of the position is in Brisbane, CA.
The Director, Regulatory Affairs, CMC will provide CMC regulatory expertise and support for development project work including CMC regulatory review for regulatory submissions and regulatory processes. This individual will represent CMC Regulatory Affairs on CMC and Regulatory Submission Teams, create timelines for complete and accurate IND/CTA and NDA/MAA submissions, ensure that clinical trials are designed to meet regulatory requirements, and guide programs to registration submissions. The individual must have the ability to work independently and also be 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
- Work closely with CMC colleagues to develop CMC regulatory submission strategies, review content, and maintain submission timelines to meet business objectives
- Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
- Lead efforts for coordinating CMC content for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications and NDAs
- Work with the CMC team on plans for NDA/MAA submissions and lead preparation
- Take a lead role in Myovant’s preparations for Regulatory Agency meetings with CMC focus
- Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and background documents for Regulatory Authority meetings
- Work with regulatory organizations and partners Europe and Asia to prepare applications, respond to queries to enable maintenance of CMC needs for clinical activities outside of the United States
- Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues
- Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders.
- Assure compliance with regulatory standards and guidance documents
- Prepare, submit, track, index, and archive electronic submissions
- Ensure that CMC-related changes are reported to authorities in accordance with regulatory requirements
- Conduct risk assessments of global CMC regulatory issues
- Liaise with Medical Writing for coordinating and publishing submission documents
- May include management of department staff and vendors
- 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.
- Employees across the Roivant companies, visitors
- Advanced degree MD, Pharm.D. or Ph.D. preferred.
- 10+ years of drug development and regulatory affairs experience in the Biotech/Pharmaceutical industry.
- Demonstrated knowledge of regulatory aspects of small molecule Chemistry, Manufacturing and Controls and quality assurance is a plus.
- Experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development.
- Experience with labeling requirements is a plus.
- Demonstrated management expertise, including leadership and development of employees.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Approximately 10% travel
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
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