- Lead regulatory science planning and execution for individual projects in Gates Ag One's product development portfolio.
- Collaborate with internal and external project partners and advise on applicable regulatory requirements and project-specific regulatory issues as assigned.
- Maintain relationships with regulatory agencies, including submissions to an array of governmental authorities required to progress the Gates Ag One portfolio of product candidates through regulatory systems to approval.
- Lead dossier preparation, regulatory study design and analyses, and submission plans.
- Ensure responses to regulatory agency queries are made in a timely manner, and that content is consistent with the regulatory strategy.
- Manage external vendors, regulatory consultants and CROs who deliver services to ensure performance.
- Ensure execution of activities to meet the defined scope, schedule, budget, and resources.
- Anticipate project-specific risks and minimize the impact of change on project delivery.
- Ph.
- Demonstrable experience in the design and execution of regulatory studies related to molecular characterization, novel protein safety assessment, agronomic and phenotypic characterization, and nutrient composition analysis.
- Regulatory experience across multiple geographies required, and experience in sub-Saharan Africa and/or South Asia highly desirable.
- Excellent oral and written communication skills, with proven ability to communicate with all levels of staff, including senior leadership.
- Validated ability to mobilize and motivate teams; set direction and approach; resolve conflict; coach performance.
- Works well under pressure.
- Proven ability to effectively use and handle external vendors, regulatory consultants and CROs.*Applicants for this role will only be considered if they are able to legally work in the country where this position is located without visa sponsorship.
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Regulatory Scientist - Saint Louis, MO, United States - Bill & Melinda Gates Foundation
Description
Regulatory ScientistLocationSt.Louis, MOTime TypeFull timeJob Requisition IDB020167About Gates Ag OneAgriculture has the power to sustain us all, but that power is dependent on equitable access to the tools and products needed to increase productivity and support food security as climate change, population growth, and gender inequality pose increasing threats.
Bill & Melinda Gates Agricultural Innovations (Gates Ag One) is a new nonprofit dedicated to ensuring high-quality, powerful crop innovations are available and accessible to those who need them most.
As a wholly owned, not-for-profit affiliate of the Bill & Melinda Gates Foundation (BMGF), Gates Ag One drives to empower the small-scale producers of sub-Saharan Africa and South Asia by amplifying the translation of innovative crop science research into affordable products for the public good.
Gates Ag One pioneers new development pathways for the most exciting crop science happening today.Through catalytic public-private sector partnerships and the careful stewardship of innovation, the organization harnesses the developed world's commercial engines to research that prioritizes low-income countries and their most important food sources.
This results in increased yields from pioneering seeds that promote food production and income where factors such as population growth and climate change pose mounting challenges – agriculture that benefits farmers, society, and the environment.
We are committed to ensuring innovative agriculture products, like climate-resilient, yield-enhancing seeds and traits, are affordable and accessible to smallholder farmers.
We are redrawing the map between discovery and market access – connecting ideas and action with an unwavering focus on smart product development.
The TeamAmongst its other responsibilities, the Global Strategy, Regulatory and Public Affairs team leads on the development and implementation of Gates Ag One's regulatory science programs and related activities, such as regulatory studies, permit acquisition, and ensuring compliance with phytosanitary and biosafety regulatory requirements.
Your RoleThe successful candidate will develop, lead and implement product-specific regulatory science plans; lead on the preparation of regulatory studies, reporting and dossier development; provide project leadership and work with cross-functional teams and external partners/organizations to ensure that regulatory studies are completed in a timely and scientifically robust manner.
This position reports to the Director, Global Strategy, Regulatory & Public Affairs.The role does not have people management responsibilities, but does work across a complex matrix of internal and external collaborators.
This is a full-time position based in St. Louis, MO. All employees are working a hybrid schedule with flexibility to work from home 2-3 days per week.What You'll Do
in a relevant subject area (e.g., biochemistry, plant molecular biology, agricultural biotechnology, crop sciences etc.) and a minimum of 10+ years of regulatory science experience in the agricultural biotechnology sector.
As a mission-driven organization, we strive to balance competitive pay with our mission and new hires are typically brought into the organization at a salary between the range minimum and the salary range midpoint.
Actual placement in the range will depend on a candidate's job-related skills, experience, and expertise, as evaluated during the interview process.
Hiring RequirementsAs part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.
Candidate AccommodationsIf you require assistance due to a disability in the application or recruitment process, please submit a request here.
Inclusion StatementWe are dedicated to the belief that all lives have equal value. We're committed to creating a workplace where employees thrive both personally and professionally.We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.
All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.
Transparency in Coverage (Machine-readable files)The Transparency in Coverage Final Rules require group health plans to disclose on a public website information regarding in-network provider rates and historical out-of-network allowed amounts and billedcharges for covered items and services in two separate machine-readable files (MRFs).
The MRFs for the benefit package options under the Bill and Melinda Gates Foundation Welfare Benefits Plan are linked below:plan reserves the right to change or terminate benefits or the plan(s) at any time.
