Regulatory Affairs Manager bei Genus PLC

Role Overview:

Genus PLC has an exciting opportunity. We are seeking a proactive and strategic Regulatory Affairs Manager to support the successful commercialization of our innovative gene-edited products. This role serves as the key link between regulatory requirements and business objectives, ensuring market readiness, compliant launches, and sustained market access across regions. This role will be responsible for translating regulatory requirements into actionable business steps and balancing compliance rigor with commercial speed. The position can be based at either our DeForest, WI or Windsor, WI locations.

 

The successful candidate can work in a culturally diverse, fast-paced and evolving regulatory environment. The candidate is an excellent communicator, who can influence internal and external stakeholders, and collaborate across teams and functional areas. This candidate is also a strategic thinker, analytical and curious learner who has strong organizational skills and can manage competing priorities.

 

The salary range for this position is $110,000 - $138,000 USD. The salary provided is a good faith estimate representative of all experience levels. Genus considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate’s work experience, location, education/training, and key skills.

You Will:

Regulatory Strategy & Market Access

• Develop & implement regulatory strategies to enable timely product commercialization across target markets.
• Map jurisdiction-specific requirements and create clear regulatory roadmaps aligned with launch timelines.
• Monitor and remain current with evolving global regulatory developments that could affect product marketability and trade.

 

Launch Readiness & Compliance

• Ensure all product labeling, packaging, and promotional claims meet regulatory requirements.
• Oversee the development of regulatory submissions, approvals, and clearances needed for commercialization and market entry.
• Ensure import/export documentation is in compliance with global trade requirements.
• Contribute to the design, implementation, and maintenance of a stewardship program for gene-edited products throughout their lifecycle, including policies, SOPs, and best practices tailored to company products and markets.

Cross-Functional Collaboration

• Collaborate with R&D, Product Development, Commercial/Marketing, Legal, and Supply Chain to integrate regulatory needs into commercialization plans.
• Provide training and guidance to commercial teams on stewardship, traceability, and compliance obligations.
• Serve as the internal advisor on regulatory risks and mitigation strategies.

Post-Launch Stewardship

• Manage renewals, amendments, and ongoing reporting obligations to regulatory agencies.
• Monitor and respond to regulatory inquiries, audits, or inspections.
• Establish KPIs and conduct internal audits to evaluate QMS and stewardship program performance.

Requirements:

Basic Qualifications: (required)

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Agriculture, Biotechnology, Food Science, or related field.
• A minimum of 8 years of experience in regulatory affairs, compliance, or product stewardship in a regulated industry (e.g., agriculture, biotech,).
• A minimum of 5 years of experience in supporting product launches and commercialization in global markets, including experience with QMS, stewardship, traceability, or identity preservation programs.
• A minimum of 5 years of experience in global regulatory approval pathways, labeling requirements, and trade compliance.

 

Preferred Qualifications:

• Master’s or PhD preferred

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 sustainably 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 [email protected]. 

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