Head of North America Regulatory and Safety

Head of North America Regulatory and Safety

About Invaio Sciences

Invaio Sciences, founded by Flagship Pioneering, is a bio platform company accelerating the leap to nature-positive agriculture. The company builds on advances in human health and digital innovation to develop biological technologies for crop health, enabling farmers to both improve yields and use more natural crop health solutions. Invaio has a presence across 3 continents and operates in a highly digitally connected environment.

About the role

We are looking for a North America Regulatory& Safety Headto work as a part of an innovative, dynamic, and collaborative Development Organization. This role is a Director/Sr. Director level position. Preferred location is Research Triangle Park, NC but could be remote depending on experience.

What you'll do

• Build and implement integrated regulatory strategies for Invaio’s innovative products and product concepts including Biologicals, Biostimulants, Peptides, RNAs, Nutrients, Antimicrobials, and synthetic chemicals. 
• Maximize cross-regional regulatory & safety data utilization and differential regulatory positioning in line with local standards.
• Map regulatory timeline processes of portfolio and potential products to define registration alternatives and market launch timeframes.
• Secure and maintain regulatory approvals of Invaio Sciences products and solutions through high quality regulatory dossiers and interactions with regulators.
• Select Regulatory Consultant companies & Contract Research Organizations (CROs) and monitor regulatory data generation and delivery of studies and dossiers.
• Position and advocate for Invaio Sciences products and solutions to regulatory bodies in region/country.
• Provide high quality regulatory advice for target markets and foresight to the North America region Development and Commercial teams to enable integration of regional project portfolios into the global business strategy.
• Provide regulatory insights into competitor products/portfolios, share current understanding and potential regulatory developments to Development and Commercial teams. 
• Create and maintain effective relations and communications with North American regulatory bodies, Rapporteur Member States, US EPA, US FDA.
• Partner with internal project teams to facilitate business decisions and represent regulatory and product safety positions
• Provide regulatory support to global and regional Invaio teams to enable and support authorizations as well as global trade of agricultural commodities treated with Invaio Sciences products or solutions
• Accountable for regulatory/safety team selection, leadership, and development.

Qualifications

• Bachelor’s Degree in Science. Post-graduate qualification (MS or PhD) preferred. 
• Solid understanding of regulatory processes in general, with knowledge in North America region (pesticides, biologicals, bio stimulants, nutrients) 
• Experience in full-cycle registration process in biologicals and chemicals, achieving successful launch
• Product safety process understanding 
• Good understanding of agriculture industry
• Proven ability to manage complex issues considering delivery timelines, cost and risks
• Collaboration across functional and geographic boundaries with excellent interpersonal skills
• Well-developed communication and presentation skills
• Fluency in English in technical discussions and advocacy. Any second language would be a plus

Invaio is an equal employment opportunity employer and is committed to a proactive program of diversity development. Invaio will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.