What are the responsibilities and job description for the Head of Regulatory and Compliance (San Carlos, CA) position at CEDENT?
As Head of Regulatory and Compliance, you will contribute to the development and implementation of regulatory strategies and regulatory compliance activities in collaboration with functional leads and external experts to support successful execution of company goals. You will lead the planning, coordination, and execution of regulatory activities necessary to ensure research and development activities are conducted in compliance with all applicable regulations.
Objectives and responsibilities
Objectives and responsibilities
- Oversee Client’s regulatory activities, ensuring alignment with project and company goals
- Ensure research and development activities are conducted in compliance with applicable regulations
- Communicate regulatory information and provide strategic direction to align development functions, external consulting subject matter experts, and internal stakeholders with regulatory and compliance requirements
- Manage the preparation of regulatory applications, studies, reports and other agency submissions in close alignment with internal development functions and 3rd party contract research organizations and consultants
- Ensure necessary scientific data, studies, and information are available to secure regulatory authorizations
- Manage field research activities for regulatory compliance requirements associated with their conduct
- Manage 3rd party collaborators supporting regulatory and field research to ensure alignment with project timelines
- Keep abreast of evolving regulatory landscape and proactively communicate potential impacts to regulatory strategies and compliance programs
- Implement documentation requirements and retention policies to ensure compliance with USDA, EPA, and other applicable regulations and standards
- Implement and oversee training programs to ensure compliance to APHIS and other applicable regulatory requirements
- Establish and maintain good working relationships with regulators
- Authorization to work full-time in the US required
- Ability to be on-site in the California Bay Area most days of the week preferred
- Bachelor's Degree in a related scientific discipline required
- Over 5 years of experience in agricultural input regulatory affairs required, more preferred
- Understanding of the US regulatory framework for modified microbial crop inputs and demonstrated success obtaining approvals for field testing
- Experience communicating with regulatory agencies
- Excellent attention to detail, organizational, and time management skills
- Strong interpersonal, written, and oral communication skills
- A culture-carrying team player excited to work at a startup with colleagues across teams and roles
