Job Title: Regulatory Affairs Specialist
Location: On-site or Remote – available for occasional travel to Davis, CA
Job Type: Full-Time
Position Overview: We are seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our Regulatory Affairs team. The ideal candidate will have a solid academic background in toxicology and ecotoxicology, with experience in the agricultural regulatory affairs field, biological products preferred. This position will provide support in the preparation of toxicology and ecotoxicology data required for the registration of microbial pesticides with the U.S. Environmental Protection Agency (EPA), as well as actively contribute to the development and compilation of full registration dossiers. You will also have the opportunity to get involved in international regulatory affairs, participate in permitting, and support the approval of field trials and coordinating sample shipments to various countries.
As a Regulatory Affairs Specialist, you will work closely with other regulatory professionals and in collaboration with exciting and innovative scientists and other departments to ensure that all regulatory requirements are met and that our products are compliant with USEPA and international standards. This is a fantastic opportunity for someone eager to learn and grow in the regulatory field.
Key Responsibilities:
- Support Toxicology & Ecotoxicology Studies: Develop study protocols and contracts, and oversee studies in GLP labs. You will provide expert insights and recommendations based on study results to support the regulatory submission and registration of microbial pesticides with the regulatory agencies.
- Regulatory Documentation: Assist in the compilation and organization of regulatory submissions, including toxicological risk assessments, studies, and required data packages.
- Permitting: Assist in applying for and obtaining permits for transit, field trial testing and commercialization of microbial products in the US and abroad.
- International Regulatory Affairs: Collaborate with the team to obtain permits for field trials and manage the shipment of product samples to other countries, ensuring local regulatory requirements are met.
- Research & Learning: Stay up-to-date with EPA guidelines, new regulations, and best practices in toxicology, ecotoxicology, and regulatory affairs.
- Continuous Learning: Take on additional responsibilities and projects as you grow within the regulatory affairs field.
Qualifications:
- Educational Background: PhD, MS or BS degree in Biology, Microbiology with emphasis on (eco)toxicology.
- Experience: 2-5 years experience in regulatory affairs, experience in biological agricultural product registration is a plus.
- Analytical Skills: Ability to assess scientific and regulatory data and make informed decisions.
- Attention to Detail: Strong organizational skills and ability to handle multiple projects and deadlines with high attention to detail.
- Strong Interpersonal Skills: Excellent communication skills, both written and verbal, and the ability to interact with cross-functional teams and work with external regulatory agencies.
- Eagerness to Learn: A strong desire to learn and develop in the regulatory affairs field, particularly in the context of microbial pesticide registration.
- Project Management: Ability to manage multiple tasks and projects, ensuring all are completed on time and in compliance with regulatory standards.
Salary and benefits:
This position will include a competitive salary along with stock options and standard company benefits. Estimated salary range is $75,000 to $100,000 depending on experience.
Contact: If you have interest or want more information please contact, in complete confidence: careers@bioconsortia.com.