Yield10 Bioscience, Inc. is an agricultural bioscience company that is using its differentiated trait gene discovery platform, the Trait Factory , to develop improved Camelina varieties for the production of proprietary seed products, and to discover high value genetic traits for the agriculture and food industries.
Our goals are to efficiently establish a high value seed products business based on developing superior varieties of Camelina to produce feedstock oils, PHA bioplastics and omega-3 (DHA+EPA) oils, and to license our yield traits to major seed companies for commercialization in major row crops, including corn, soybean and canola.
Yield10 is headquartered in Woburn, MA and has an Oilseeds Center of Excellence in Saskatoon, Canada.
Yield10 is searching for a Regulatory Affairs Specialist. The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulatory matters of field trials, and supporting other regulatory activities including submissions under the Secure Rule.
The successful candidate will interact closely with our plant science teams in the U.S. and Canada to support crop yield trait development and testing.
This position requires attention to detail, a strong work ethic and excellent communication skills with the ability to understand and communicate crop science methodologies and regulatory guidelines to internal multidisciplinary teams.
This position reports to our Director of Regulatory Affairs.
RESPONSIBILITIES
- Support the regulatory program for a range of genome edited and biotech traits as well as products produced in Camelina
- Support our interactions with USDA-APHIS, FDA and EPA as well as other related agencies
- Prepare and obtain permits and notifications for field release and movement of regulated organisms
- Support all regulatory aspects of and maintain records related to execution of field trials
- Support management of shipment and receipt of regulated materials
- Support management of internal regulatory inventory and documentation files
QUALIFICATIONS
- Candidates should have a B.S. or M.S. in a field applicable to plant science
- At least 5 years Ag industry experience with responsibilities closely tied to regulatory efforts
- Experience in regulatory permitting in the U.S. and Canada would be ideal
- Candidates must have an excellent ability to work supportively in a multidisciplinary team environment
Yield10 is an equal opportunity employer offering excellent career opportunities as well as a competitive compensation and benefits package.
Principal Regulatory Affairs Specialist
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. Conceive of and Implement the Regulatory Strategy in ...
Global Senior Specialist, Publishing - Regulatory Affairs
The Regulatory Operations Senior Publishing Specialist is responsible for the planning, creation, and submission of regulatory submissions. The Senior Publishing Specialist provides regulatory operations expertise to cross-functional submission project teams, promoting and bringing excellence in pla...
Regulatory Affairs Specialist
Uses regulatory knowledge to provide subject matter expertise to clients and management for efficient EHS&T services when applicable. Monitors applicable regulations relevant to specific job duties while maintaining a broad understanding of current regulatory landscape so that appropriate actions ca...
Regulatory Affairs Specialist
The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to + investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an op...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist. Responsible for managing product based regulatory activities of a medical device company that designs, manufactures, sells, and services medical imaging equipment. Manage preparation of regulatory documentation to facilitate the commercialization of new products...
Program Manager — Biotechnology Crop Traits
Our goals are to efficiently establish a high value seed products business based on developing superior varieties of Camelina to produce feedstock oils, PHA bioplastics and omega-3 oils, and to license our yield traits to major seed companies for commercialization in major row crops, including corn,...
Clinical Regulatory Affairs Specialist
As the Clinical Regulatory Affairs Specialist, you will play a critical role in managing essential documentation and regulatory submissions that are key to our clinical trials' success. Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field. You will ensure the success of clinica...
Specialist, Regulatory Affairs
The Regulatory Affairs Specialist performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to the FDA for approval of novel platforms. Support and eventually manage interactions with regulatory agencies including respons...
Senior Regulatory Affairs Specialist-Animal Tissue
Senior Regulatory Affairs Specialist-Animal Tissue. Will report to the VP of Regulatory Affairs . Candidate will be responsible for regulatory activities related to Animal Tissue . Respond to regulatory authorities of any questions related to animal tissue. ...
Senior Regulatory Affairs Specialist-Animal Tissue
Title: Senior Regulatory Affairs Specialist-Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary. Able to t...