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Regulatory Affairs Manager

Employer
GreenLight Biosciences, Inc.
Location
Durham, North Carolina
Start date
Feb 2, 2023

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time

ABOUT GREENLIGHT

At GreenLight we are working to solve two of the world's greatest problems: global food insecurity and equal access to vaccines and the associated health benefits. Unlike most corporations who can be required to put profits ahead of other principles, GreenLight is one of the first Public Benefit Corporations to be publicly traded and have a charter that requires a focus on how it benefits its employees, community and society and has a broad portfolio addressing key issues in plant health and human health (Nasdaq: GRNA) by leveraging the full potential of dsRNA and mRNA. The GreenLight team is a  little over 260 people across our headquarters in Lexington, MA, an R&D facility and an R&D facility in Research Triangle Park, NC. GreenLight also has a biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity, protect bees and other pollinators, treat rare diseases as well as develop vaccines.

At GreenLight, we believe inclusion is the way forward. We celebrate the power of working together to address humanity’s challenges, meet the needs of underserved populations, and push the boundaries of scientific discovery. Fueled by our aspiration for a true sense of belonging, our talented teams embody the principles of diversity and equality as we strive to bring food security, medicine, and healthcare to everyone—paving the way for a sustainable future. For more information, visit www.greenlightbio.com.

GreenLight Biosciences is seeking a highly motivated Regulatory Affairs Manager to join our Crop Protection team. Greenlight is developing cutting edge RNA technologies that address key challenges in global Crop Protection. In this role you will be integrally involved in the development and registration of novel biochemical products. The ideal candidate will have registration experience as well as knowledge of biochemical product regulations. Strong technical, organizational, and communication skills, attention to detail, as well as the ability to maintain a commitment to excellence and high-quality work in a fast-paced milestone driven company, are essential.

Responsibilities:

Support supervisor in all aspects of international, federal and state development and registration for GreenLight products. This process typically involves:

Working with regulatory team to plan, assist and manage electronic submission packages to regulatory authorities (e.g.: EPA CDX);

Assure compliance with US Environmental Protection Agency (EPA), Canada Pest Management Agency (PMRA) and other regulatory authorities regulations related to formatting and organizing documents files in preparation for submission to these regulatory authorities.

Work with internal stakeholders to assist annual reports required by authorities (e.g.: EPA Pesticide production establishment reports).

Prepare and maintain US State Registrations supporting internal business plan.

Interfacing with the appropriate regulatory agency (EPA, CDPR, etc.) contacts.

Independently preparing more routine submissions.

Maintaining appropriate files and databases to document such activities;

Being regulatory point of contact with other GreenLight team members to meet registration objectives and address regulatory concerns that impact the businesses, such as amending federal and/or state registrations/labels.

Requirements:

master’s degree or higher in a relevant science (preferred);

previous FIFRA experience; US state registration, label management, international and biochemical experience are a plus;

data management system implementation and management.

good communication skills, be highly organized and have a strong attention to detail.

have a good command of the English language, and an ability to do technical writing and critically review documents;

be proficient in using the following: Microsoft Office products (Word, Excel, PowerPoint, Outlook, Smartsheets is a plus); Adobe Acrobat; other software.

Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

GreenLight requires proof of COVID-19 vaccination for its employees.

 

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