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 qualified, highly motivated, experienced individual for the position of Senior Associate/ Manger, Regulatory Affairs CMC . The position reports to the Director, Regulatory Affairs, CMC. The location of the position is in Brisbane, CA.
The Senior Associate/ Manager, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and 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 and Responsibilities
- Work independently, coordinate, review and prepare clinical trial applications and amendments, ensuring compliance with the Food and Drug Administration (FDA) and international regulations and interpretations.
- Provide appropriate support for marketing authorization applications under manager’s supervision.
- Represent Regulatory Affairs on Study Management Teams (SMT) for the clinical development and clinical trials of investigational new products.
- Review and approve documentation required for release of clinical supplies to clinical sites, as needed.
- Assess change controls for regional regulatory impact and record assessment to manage lifecycle of development and commercial products.
- Coordinate regulatory sections and lead adjudication meetings.
- Review IND annual reports/ DSURs, IMPD, IMPD amendments for content accuracy and regulatory messaging.
- Support the regulatory strategy, coordination, preparation and submission of regulatory documents such as HA responses, pre-meeting briefing packages, and CTD dossiers for HA approval. Alert the Regulatory Management to issues and potential problems, delays and/or deficiencies, and make recommendations as appropriate.
- Conduct regulatory research and competitive analysis to support regulatory strategy development and identify submissions considerations.
- With assistance of project regulatory lead, develops and implements regulatory strategies and guidance based on U.S. and International requirements.
- Participates in regulatory audits/inspections as required.
- Schedule, track project/operational activities, such as IND, IMPD, NDA adjudications, reviews and approvals.
- Develop and maintain knowledge of regulatory requirements independently and with line manager
- Prepare Regulatory Standard Operating Procedures and Work Procedures
- Other Duties as assigned
Core Competencies, Knowledge, and Skill Requirements
- Contribute to local process improvements, which have an impact on the working of the Regulatory CMC function or other departments.
- Work cross-functionally within a matrixed organization.
- Primarily plans, schedules, and arranges own activities in alignment with project goals and deadlines.
- Must be capable of leading a small team in preparation of regional submissions.
- Must work well under deadlines and have excellent attention to detail. Strong computer and organizational skills required. Work is performed under limited direction of a senior Regulatory Affairs professional.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Knowledge of FDA and EU regulations.
- Knowledge of foreign regulations and ICH.
- An understanding of CMC and drug development.
- Experience in the preparation and submission of INDs, CTAs, and amendments.
- 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.
- 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).
- Bachelor’s Degree with a minimum of six (6) years of relevant training or industry experience preferably in a GMP environment, OR
- Master’s Degree with a minimum of four (4) years of relevant training or industry experience preferably in a GMP environment.
- A minimum of three 4-6 years in regulatory affairs, CMC is required.
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- 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.
If you require any accommodations, please email .
Equal Employment Opportunity
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