Regulatory Science Manager

Regulatory Science Manager

About the role....

The Regulatory Science Manager is responsible for creating and ensuring implementation of a data generation plan to support consultations and submissions for Inari products globally.  The Manager also ensures that protocols are appropriately developed and implemented.  Additional responsibilities include ensuring that data generated is aligned with the timelines for the submission, consultation of the regulatory plan - the scope includes  Genetically Modified Organisms (GM post patent and Gene-edited GM), Gene-edited and Crop Protection products.  This job reports to the VP of Regulatory and is based in West Lafayette, IN or Cambridge, MA.

As the Regulatory Science Manager, you will…

• Create a data generation plan according to the global regulatory plan to enable consultations and submissions for Gene-edited, GMO and Crop Protection products.
• Support the organization in analyzing global regulatory data requirements 
• Works closely cross functionally to ensure data generation and integrity, to be used in consultations and submissions
• Create or adapt appropriate protocols for required field and lab regulatory characterization and safety data trials
• Manage the overall data generation strategy including CRO and internal resources. 
• Analyze and manage budget to support regulatory data generation activities
• Ensure that other functions have support resources in place to generate regulatory data as needed
• Execute and track the aligned data generation and uses according to the overall regulatory strategy for consultations and submissions 
• Consolidate Inari expertise to manage publications and information generation with regulatory implications.  Represents Inari in technical regulatory discussions including agency visits
• Create and execute internal reviews as appropriate
• Represent Inari in advocacy activities focused in regulatory technical developments
• Work closely with other Regulatory functions (such as Regulatory Science and Regulatory compliance) and engage proactively in business-partnering with the Science, Product and Commercial organizations. 

 You Bring…

• Minimum MS, preferably PhD  in biological sciences, preferably agricultural sciences, or related disciplines;
• 5-7 years of work experience in biology related fields, preferably in agriculture.
• Minimum 5 years work experience in generating regulatory data and data submission plans and support interactions with US regulatory agencies (USDA, EPA and state agencies); additional experience with other international agencies preferred
• Strong business acumen, ability to understand strategies and business plan and co-develop integrated Regulatory plans in service of delivering the business objectives timely
• Self-starter, pro-active communicator and highly organized working style
• A strong sense of purpose and drive to develop unique, high impact solutions.
• Adaptability and enthusiasm for new challenges, innate curiosity, and a passion for learning.
• Creative and strategic thinking, willingness to be bold and take risks, and the ability to recognize and learn from failure.
• A collaborative mindset that is open to giving and receiving ideas, perspectives, and feedback.
• Ability to work independently while embracing the company values and culture, and to deliver on responsibilities within a highly collaborative environment.
• Ability to effectively communicate with a diverse range of individuals and audiences.