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Job: Regulatory Affairs Specialist, Novozymes, Franklinton, NC

General Information


Job title:
Regulatory Affairs Specialist
Job location:
Franklinton, NC  27525 United States
Requisition code:
Date posted:
06/24/2020
Compensation:
Job category:
Regulatory Affairs
Employment type:
Full time

Job Description


Pioneer a brighter future
At Novozymes, we work in close partnership with our customers and the global community to make an impact and help create a better world. For those around us, for each other and for the next generation. We use science to advance industries, and as part of Supply Operations, you will produce and deliver the biological solutions that boost our customers’ business and pave the way for a brighter future.

Regulatory Affairs Specialist – Microorganisms for Agricultural Bioyield Applications
The Novozymes Regulatory Affairs Team seeks an experienced professional to lead regulatory activities as part of our Americas team in our bio-agricultural (BioAg) business area. This role requires someone who is an expert on US regulations, including state and USDA APHIS regulations, for microbial products designed to enhance crop yields in bioyield applications. You’ll be global regulatory lead on multiple projects at a time, providing guidance and developing regulatory plans for project teams, coordinating regulatory plans with other regions, and ensuring compliance throughout the entire project life (scoping to post-launch). The successful candidate will regularly demonstrate out of the box thinking when working with novel applications and be able to effectively leverage their expertise to develop registration strategies. They will lead our internal APHIS working group to share information and provide guidance on requirements for laboratory, greenhouse and field permitting. As our Microbial Regulatory Specialist, you will also research, review and monitor current and proposed US laws and regulations pertaining to BioAg products. You will share those insights with our global regulatory, product development, and commercial partnership teams to contribute to and lead the development of regulatory strategies which ensure compliance and speed to market. You will be expected to contribute to maturing corporate policies for regulatory assessments of microorganisms for BioAg applications.

Desired Qualifications:
•BS/MS in the Life Sciences (Microbiology, Molecular Biology, Biochemistry) required with a minimum of 5 years of relevant work experience
•Experience / knowledge in regulatory working with the application, scientific and technical aspects of microorganisms used for bio-agricultural applications is highly preferred
•Technical knowledge of biotechology tools for enhancing the properties of naturally occurring microbes and their regulatory implications is strongly preferred
•Candidates who have an existing network within and experience working with Regulatory Authorities such as USDA-APHIS, US State Departments of Agriculture, and related Trade Associations and other industry groups have high preference
•Strong experience in working effectively with external partners and in successfully handling highly confidential information
•Strong project management, organizational, written/oral communication skills and ability to work and lead effectively in a global team environment
•Good interpersonal skills and interest in working and interacting with diverse cultures
•Proven aptitude with a variety of computer disciplines: word processing, building presentations, spreadsheets and database skills
•Travel within NA as well as international travel (15%) with periodic trips to Copenhagen Denmark required
•The position is located in the greater Raleigh, NC area, specifically in Franklinton, NC, USA. The position will require 3-4 days per month of work in our offices in Research Triangle Park in NC.
•Ability to work in the U.S. without sponsorship.

Rethink tomorrow
Novozymes is the world leader in bio-innovation. We create tomorrow’s solutions by applying technology to nature, to the benefit of both our customers’ bottom line and the planet. Novozymes serves a broad array of industries using enzymes, microorganisms, biopolymers, and biopharmaceutical ingredients.

With over 700 products in 130 countries, Novozymes’ bio-innovations improve industrial performance and safeguard the world’s resources because they represent superior and sustainable solutions for tomorrow’s ever-changing marketplace.

Novozymes 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.

Apply online at www.novozymes.com/careers

Job Requirements


Desired Qualifications:
•BS/MS in the Life Sciences (Microbiology, Molecular Biology, Biochemistry) required with a minimum of 5 years of relevant work experience
•Experience / knowledge in regulatory working with the application, scientific and technical aspects of microorganisms used for bio-agricultural applications is highly preferred
•Technical knowledge of biotechology tools for enhancing the properties of naturally occurring microbes and their regulatory implications is strongly preferred
•Candidates who have an existing network within and experience working with Regulatory Authorities such as USDA-APHIS, US State Departments of Agriculture, and related Trade Associations and other industry groups have high preference
•Strong experience in working effectively with external partners and in successfully handling highly confidential information
•Strong project management, organizational, written/oral communication skills and ability to work and lead effectively in a global team environment
•Good interpersonal skills and interest in working and interacting with diverse cultures
•Proven aptitude with a variety of computer disciplines: word processing, building presentations, spreadsheets and database skills
•Travel within NA as well as international travel (15%) with periodic trips to Copenhagen Denmark required
•The position is located in the greater Raleigh, NC area, specifically in Franklinton, NC, USA. The position will require 3-4 days per month of work in our offices in Research Triangle Park in NC.
•Ability to work in the U.S. without sponsorship.
(Job number: 3915603)
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