Sr. Regulatory Affairs Specialist - Animal Biosolutions
West Allis, WI  / Franklinton, NC 
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Job Description

Location:West Allis, WI or Franklinton, NC
State:Wisconsin; North Carolina
Country:USA

Our purpose points the way
In Novonesis, we know that solutions rooted in biology can help solve humanity's biggest challenges. Since we began more than a century ago, this has been our guide. It's how we've gotten so far. And it's how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.

We're here to better our world with biology.

Join us as our new Sr. Regulatory Specialist

This position works under general direction and is primarily responsible for responding to internal and external inquiries related to the company's animal biosolutions products and the regulations governing them for North America. This position can be located near our West Allis, WI or Franklinton, NC facilities.

In this role, you'll make a difference by:

  • Researchingand preparingtimely and accurate responses to customer inquiries regarding the domestic and international regulatory status of products, specifications, allergens and certifications.

  • Assistingin the operation of systems and procedures to ensure timely and accurate data collection, maintenance and delivery of consistent regulatory information throughout the organization.

  • Communicatingwith government agencies (FDA, CBP, USDA, CFIA) on a regular basis regarding regulatory compliance of our products and processes.

  • Monitoringregulatory changes affecting company products and communicates to appropriate inter-company stakeholders.

  • Supportingthe business unit division regarding securing registrations, certifications and regulatory dossiers for internal use and submission to government and 3rd party entities.

  • Supportingthe sales team and business support with assisting customers on ingredient regulation and labeling requirements and internal formulation and label reviews.

  • Supporting to 3rd party certifying body requests and audits (NGVP, OMRI, etc.)

  • Supportingglobal regulatory colleagues in preparing dossiers, obtaining certificates of free sales, legalization of documents, and sample coordination. This includes, but not limited to, China, Mexico, and Latin American countries.

  • Supporting to External Affairs activities.

  • Conducting risk assessments and clearly communicate risk to Regulatory Affairs management and colleagues, and the business units as needed.

  • Providingleadership, support, training, and guidance to Regulatory Affairs Specialists where appropriate.

  • Contributingin an engaged and impactful manner as a team member of the local and global Animal Biosolutions regulatory teams.

To succeed you must hold:

  • Ability to read, write and speak English fluently. Abilityto effectively communicate both in oral and written form.

  • Possess a basic understanding of international animal food law and regulations with focus on North America.

  • Must be a self-starter and be able to multi-task.

  • Possess an inquisitive mind and the ability to redirect or reword inquiries to various agencies to attain the required information.

  • Ability to assess broad impact of decisions, and where necessary conduct formal and informal impact assessments in collaboration with the Business Units and with the guidance of Regulatory Affairs Manager.

  • Ability to use ERP system (i.e. SAP) to access raw material information, formulas and/or processes.

  • Possess a working knowledge in Microsoft Office programs.

  • These characteristics are normally acquired through a Bachelor's degree in a scientific or technical area with five to seven years regulatory experience.

  • Ability and willingness to travel domestically and internationally as needed.

Could our purpose be yours? Then apply today!

Application deadline: 7/12/24

At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.

Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.

Want to learn more?
Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com

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EQUAL OPPORTUNITY EMPLOYER OF MINORITIES, FEMALES, PROTECTED VETERANS, AND INDIVIDUAL WITH DISABILITIES.
•Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
•Please view Equal Employment Opportunity Posters provided by OFCCP here.
•The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5 to 7 years
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