DuPont Associate Manager of Regulatory Affairs in Palo Alto, California
Associate Manager of Regulatory Affairs (Job Number: 191430W-01)
Product Stewardship & Regulatory (PS&R) Associate Manager /Manager – North America Region
We are currently seeking an outstanding individual to join our Product Stewardship and Regulatory (PS&R) Team.
Locations: Palo Alto, CA (Wilmington, DE location may be considered)
Primary function: Drive regulatory document development and compilation for registration/market access as well as pre and post launch activities all of IB businesses with a focus on the feed application portfolio.
Prepareand/or oversee compilation of regulatory dossier submissions to US and Canadianauthorities with a primary focus on animal feed products, in conjunction withglobal PS&R team and/or external regulatory consultants.
Advise R&D teams on PS&R requirements and coordinatecross-regionally with PS&R resources in the development and launch approvalof new products.
Evaluateimplications of product and process changes, and advise innovation teams andproduct management on regulatory & stewardship implications of options andregulatory paths for product clearance of new IB product lines. Although primary focus is on AnimalNutrition, projects for other IB businesses may involve applications in food contact,food processing, personal care, detergents, fuel, textiles, biomaterials, and pharma.
Contributeto global regulatory compliance programs for IB marketed products inconjunction with global PS&R team and product management.
Managementof US state feed license program
Participatein project prioritization and reporting within the PS&R function and withthe IB businesses.
Continuouslyassess the regulatory landscape, predict, and communicate impact to IB teams.
Coordinate advocacy efforts to influence national regulations acrossUS and Canada in areas related to the IB businesses through strongleadership in trade associations and building/maintaining strong relationshipswith regulatory authorities.
Translategoals of the company into a strategic plan for his/her areas of regulatoryresponsibility.
Communicateinternal regulatory strategies and policies, and implementation in areas ofresponsibility.
Together, We Can Solve the World’s Greatest Challenges
The solution to many of the most fundamental challenges facing the world today can be found in science. But providing for the food, energy and safety needs of a growing population will require more than science alone. It will require many people working together to devise solutions that improve the lives of people everywhere. DuPont has a rich history of scientific discovery that has enabled countless innovations and today, we’re looking for more people, in more places, to collaborate with us to make life the best it can be.
About DuPont Industrial Biosciences
DuPont Industrial Biosciences (IB) comprises an unmatched portfolio of capabilities in industrial biotechnology and biobased solutions. The unique combination of agricultural, biotechnology, chemical and material science capabilities allows DuPont Industrial Biosciences to deliver cost-effective products with superior performance and sustainability aspects to a range of industries. Bringing together the expertise from Danisco, Genencor, and DuPont has yielded a unique combination of strengths in enzyme technology, materials science, and bioprocessing. We call it Powered by DuPont™ Genencor® Science. It’s what powers the innovations to help solve some of the world’s greatest challenges.
GeneralCompetencies (Minimum 3-8 Years of Experience):
Experience in preparing clear, accurate regulatory submissions/dossiersor similar documents ( e.g ., technicalreports/scientific papers, risk assessments).
Successfully impacted product introductions by providing regulatory &safety guidance and/or successfully influenced decisions to implement change.
Experienced in interaction with and education of regulatory agencies andtrade associations and track record in product clearance/registrations andregulatory advocacy.
In depth knowledge and recognized for leadership & innovation inmanaging regulatory submissons to FDA, EPA or Canadian authorities.
Successfully implemented complex/controversial regulatory policies andstrategies, and/or systems to improve regulatory data communication.
Demonstrated forming influence on the department (can be innon-technical/scientific manner) and/or strong impact on the success of futureproducts and processes.
Excellent communication (written and verbal) and people skills,attention to detail, ability to work with & lead teams
Excellent leadership, interpersonal and coaching skills to drive anemployee-driven work culture.
Competency in computer/software tools sufficient for the role and ofsystems needed to manage regulatory knowledge and submissions.
Demonstrated ability to work effectively in a fast-pacedteam driven environment.
Demonstrated continuous learning mindset and flexibility toexpand expertise into new industries, applications, and jurisdictions.
BS/MS in biochemistry, biology, toxicology, regulatory, or applied sciences such as animal nutrition or food science. Ph.D. preferred.
Primary Location: NA-United States-California-Palo Alto
Organization: Industrial Biosciences
Education Level: Bachelor's Degree (±16 years)
Employee Status: Regular
Job Type: Entry Level
DuPont is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information. For US Applicants: See the “Equal Employment Opportunity is the Law” poster.