What are the responsibilities and job description for the Regulatory Affairs Manager/Sr. Reg. Affairs Specialist position at Novozymes (part of Novonesis)?
Are you ready fora new beginning?
We need your talent, knowledge and dedication to better our world with biology.
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 Regulatory Affairs Manager or Sr. Regulatory Affairs Specialist!
Welcome to....
The Novonesis Plant Biosolutions Regulatory Team. Novonesis seeks an experienced Regulatory Affairs professional to join our US team with primary responsibility in the biopesticide area that includes microorganisms, enzymes, and other novel microbial-derived technologies.
In this role you'll make an impact by:
As our Regulatory Affairs Manager or specialist, you will engage with our global regulatory team, internal stakeholders and external partners to develop regulatory strategies and plans to ensure efficient registrations and required documentation are in place for compliant sales into country(ies) of responsibility which will be mostly US based.
Responsible for providing regulatory guidance throughout the product life cycle from early assessment through post launch activities.
Responsible for aligning within global regulatory and across global functions on data requirements to author and ensure high quality dossiers.
Develop and implement strategies for product submissions, prepare regulatory pre-submission documents and lead submission meetings.
Responsible for the regulatory submission to regulatory agencies and ensuring timely approval.
Responsible for following, understanding, interpreting and communicating current and potential changes in regulatory standards and/or requirements in the country(ies) of responsibility to relevant internal Regulatory colleagues and key stakeholders.
Serve as a subject matter expert on agricultural regulations and coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
Organize and conduct training sessions to enhance the organizations knowledge of working in a regulated environment.
To succeed you must hold:
Minimum BS (MS preferred) in the Life Sciences (Microbiology, Molecular Biology, Biochemistry) with a minimum of 6 years of relevant regulatory and registration work experience for Sr. Reg Affairs Specialist and 9 years for Reg. Affairs Manager.
Experience / knowledge in Regulatory working with the application and scientific and technical aspects of microbial technologies used for bio-agricultural applications.
Current experience working within Regulatory Authorities such as US EPA, FIFRA, USDA, FDA, US state ag departments, and related Trade Associations and other industry groups.
Strong experience in working effectively with external partners, and in successfully handling highly confidential information.
Fluent in English (speaking, reading, writing).
Proven aptitude with a variety of computer disciplines (Microsoft, Veeva).
Good interpersonal skills and interest in working and interacting with diverse cultures.
Strong project management, organizational, written/oral communication skills with ability to effectively manage multiple projects simultaneously in a team-oriented environment.
Travel 10-15% within North America with periodic trips to Copenhagen Denmark required.
The position is ideally located in the greater Raleigh, NC area; however, other locations will be considered as long as ability to travel to the Raleigh, NC area once per quarter.
Ability to work in the U.S. without sponsorship.
The salary range is $100,000-125,000 for Sr. Regulatory Affairs Specialist.
The years of experience will be evaluated for a manager role. The salary range is $125,000 - 145,000.
Benefits you will enjoy:
401(k) with up to a 9% company contribution!
Minimum of 3 weeks vacation plus 12 holidays and 2 weeks of Wellness Time
Health, Dental, Vision & Life insurance
Healthcare savings account option with generous employer contribution
Employee assistance program
Parental leave
Tuition reimbursement
All benefits begin on your first day!
Could our purpose be yours? Then apply today!
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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Salary : $100,000 - $125,000
