Regulatory Science Specialist

Role Overview:

Genus PLC has an exciting opportunity. We are looking for a Regulatory Science Specialist to develop and manage regulatory submission documentation and ensure compliance of Genus research and product development activities with applicable laws and regulations. The position is located in our Deforest office and remote work is an option. The Regulatory Science Specialist will execute the plan for development and submission of global registration dossiers related to the new products developed through gene-editing and other new technologies. The chosen candidate is accountable for establishing Regulatory Science strategy to obtain timely global approvals, including addressing country specific requirements, by aligning and collaborating with cross-functional teams. As part of our Global Regulatory team, youll be at the forefront of our business and building solutions that ultimately provide genetic improvement to help nourish the world.

Essential Duties and Responsibilities:

• Lead the development of regulatory science data for approvals and product registrations.
• Develop and submit all necessary documents for global regulatory approvals for new products developed via gene-editing and other new technologies.
• Develop and manage all approvals for regulated research and development activities to ensure compliance with all domestic and global regulations.
• Identify and mitigate potential risks associated with regulatory submission and/or associated timelines, and action planning as needed.
• Develop and coordinate responses to any questions received from regulatory agencies.
• Work closely with regulatory compliance and quality assurance staff
• Assist with development of budget and forecast projections for the regulatory science function and key regulatory phase projects.

Requirements:

Basic Qualifications: (required)
Advanced degree required in Animal Science, Plant Science, Molecular/Cellular Biology, Genetics, or other field relevant to agricultural biotechnology.
Familiarity with gene editing technology and global biotech regulations for in-country production and import of biotech products
A minimum of 5 years regulatory science and compliance experience
Ability to educate relevant parties on global regulations and policies that require compliance
Demonstrated success and extensive knowledge of applicable government regulations and in regulatory filings for US and other key countries/regions (and ability to stay current)
Demonstrated ability to work successfully with cross-functional teams and influence to achieve deliverables
Ability to work in and maintain performance expectations in a fast-paced environment.
Strong project management and written and verbal communication skills with the ability to communicate in an organized and concise manner.
Self-starter capable of personal and professional growth
Ability to work both autonomously and collaborate across teams and functional areas
Work requires continual attention to detail and ability to establish priorities and meet deadlines
Proficient in Microsoft Office and other relevant software applications
Ability to travel when required both domestically and internationally, maximum 25%
Authorized to work in the U.S. without sponsorship

Preferred Qualifications:

Demonstrated experience making regulatory submissions to Food and Drug Administration/Center for Veterinary Medicine (FDA-CVM) and familiarity with FDA-CVM e-submitter systems preferred
Prior experience with FDA-CVM animal biotechnology regulations (GFI #187), or other US regulatory systems for oversight of agricultural biotechnology, a plus
Certifications in regulatory affairs a plus

Business Overview:

Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange. Genus PLC has a presence in over 70 countries and a global workforce of over 3,000 employees and growing. We are a worldwide leader in porcine and bovine animal genetics, partnering with farmers to transform how we nourish the world a mission that is important to a sustainable future.

Our vision is clear: Pioneering animal genetic improvement to help nourish the world.

Benefits Overview:

At Genus we offer a competitive salary. Benefits include health, dental, vision, FSA/HSA, long and short-term disability, 401K, tuition reimbursement, paid holidays and ETO (employee time off). This position will have opportunity for growth.

Equal Employment Opportunities:

Genus is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Genus prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Genus conforms to the spirit as well as to the letter of all applicable laws and regulations.

Recruitment Fraud Warning:

Genus plc will never ask you to provide fees or payment for computer, software, or other equipment or supplies during the recruitment and/or onboarding process. If you have any questions about your individual application, please contact the Genus Talent Acquisition team at recruiting@genusplc.com.

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