Sr. Regulatory Science Manager

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.

Role Overview

Genus PLC has an exciting opportunity. We are looking for a Sr. Regulatory Science and Compliance Manager to develop and manage regulatory submission documents and ensure compliance of Genus research and product development activities with applicable laws and regulations. This role will work closely with Sr. Regulatory Affairs Manager to develop and implement a plan for global registration dossiers related to the new products developed through gene-editing and other new technologies and track regulatory acclivities and/or issues and risks and proactively bring to the attention of the leadership as necessary. A person in this role is accountable for establishing Regulatory Science strategy to obtain global approvals and ensure that all studies are aligned with cross-functional teams including Research and Commercial functions.  A person in this role is accountable for developing science-based strategies to address countries specific regulatory requirements and enable timely approvals.   

Essential Duties and Responsibilities

• Work closely with Head of Regulatory Science and Externa Affairs to support development of regulatory science data for regulatory approvals and product registrations.
• Responsible for developing all necessary documents necessary for global regulatory approvals for new products developed via gene-editing and other new technologies; Lead and coordinate regulatory science activities.
• Responsible for development of annual and 5-year budget projections for the regulatory science function and key regulatory phase projects.
• Responsible for all aspects of compliance, quality control and stewardship through the discovery, development, launch and post approval stages of Genus Products
• Responsible for developing and managing all approvals for conducting research and development activities, reports, SOPs, trainings, audits and corrective actions for compliance with domestic (FDA/CVM and related agencies) and global regulations.
• Conduct project risk identification and mitigation action planning working closely with the Sr. Regulatory Affairs Manager, Project Manager, and cross-functional product development team.
• Provide leadership and direction for addressing questions from global regulatory agencies to mitigate any impact on compliance status and success of products approvals.
• Contribute to recruitment/selection of staff; development and coaching/mentoring regulatory and technical professionals as the department grows.

Requirements

Education & Experience:• M.Sc. or Ph.D. degree required in Animal Science, Plant Science, Life Sciences generally or another relevant field.• 7 years regulatory science and compliance experience with leadership experience at a manager level • Ability to inform and educate managers and department heads 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.• Familiarity with gene editing technology and global biotech regulations for in-country production and import of biotech products. • Demonstrated experience in project management, regulatory science, and compliance with regulations. • Dynamic public speaker possessing the ability to communicate with and gain the confidence of people form a variety of sectors and settings.• Self-starter capable of personal and professional growth• Travel maximum 25%, both domestically and internationally.

Knowledge/Skills:• Considerable knowledge of the agricultural business including crops and farm animals.• Extensive experience in regulatory filings for US and other key countries/regions.• Exceptional written and verbal communication skills.• Ability to explain global regulations, policies, or procedures.• Extensive knowledge and understanding of compliance with regulations globally.• Advise others on regulatory and compliance matters.• Evaluate applicable laws and regulations to determine impact on company activities.• Excellent ability to prepare and provide technical review of data or reports.• Coordinate regulatory science documentation activities.Capabilities and behaviors:• Reflects Genus R&D’s aim of having the strongest talent in the industry.• Lives and displays the Genus Values and behaviors at all times in day-to-day work.• Maintains professional verbal and written communications with co-workers, internal and external customers, and vendors at all times.• Flexible with job responsibilities and consistently strives to be an effective team member.• Strives to advance skills and displays a willingness to accept future development.• Actively participates in Company training opportunities to further develop applicable skills.• Gains a thorough understanding of the Company’s business and the department’s role within the company.

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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.