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.
The Senior Director, Regulatory 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. As such, the candidate will have direct influence on the decision-making processes within the scope of CMC related activities for Myovant. 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 in 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
- Managing responsibilities for department staff and vendors
- Recruit, develop, manage and mentor regulatory professionals and drive a culture of excellence that motivates employees to perform at their highest ability. Reward and recognize employees and teams who take initiative beyond expectations to advance business goals
- 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.
- Daily demonstrates a positive, ‘can do’; Team player willing to roll up her/his sleeves as the situation requires to get the right result.
- Skilled in working in a fast-paced environment managing multiple competing tasks and demands combined with hands-on attention to detail with the ability to step back and think holistically.
- Strategic thinker, planner, and implementer with a proven track record practicing sound and timely judgment; examines and understands issues from multiple perspectives or points of view in a matrix environment.
- Strong team leadership skills with the ability to foster high-performing teams (both functionally and cross-functionally) as well as a to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures and discipline.
- Inspires people and treats people with respect; works ethically and with integrity; exhibits and fosters open and honest communication style to foster trust-building behaviors in all levels of interaction
- Capability to create, lead and direct implementation of operational strategies through management of organization and teams
- Ability to build and manage a high performing group; attract, retain and coach best talent. Develops direct reports in their career paths, particularly ensuring that a successor is evolved.
Communication & Interpersonal Skills
- Excellent listening, verbal and written communication and presentation skills, as this position will interface with all levels within the organization, regulators, partners and key opinion leaders.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Advanced degree MD, Pharm.D. or Ph.D. preferred.
- 12+ 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.
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Equal Employment Opportunity