Associate Manager of Regulatory Affairs (191430W-01)
Associate Manager of Regulatory Affairs
Palo Alto, CA
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.
- Prepare and/or oversee compilation of regulatory dossier submissions to US and Canadian authorities with a primary focus on animal feed products, in conjunction with global PS&R team and/or external regulatory consultants.
- Advise R&D teams on PS&R requirements and coordinate cross-regionally with PS&R resources in the development and launch approval of new products.
- Evaluate implications of product and process changes, and advise innovation teams and product management on regulatory & stewardship implications of options and regulatory paths for product clearance of new IB product lines. Although primary focus is on Animal Nutrition, projects for other IB businesses may involve applications in food contact, food processing, personal care, detergents, fuel, textiles, biomaterials, and pharma.
- Contribute to global regulatory compliance programs for IB marketed products in conjunction with global PS&R team and product management.
- Management of US state feed license program
- Participate in project prioritization and reporting within the PS&R function and with the IB businesses.
- Continuously assess the regulatory landscape, predict, and communicate impact to IB teams.
- Coordinate advocacy efforts to influence national regulations across US and Canada in areas related to the IB businesses through strong leadership in trade associations and building/maintaining strong relationships with regulatory authorities.
- Translate goals of the company into a strategic plan for his/her areas of regulatory responsibility.
- Communicate internal regulatory strategies and policies, and implementation in areas of responsibility.
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.
General Competencies (Minimum 3-8 Years of Experience):
- Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents (e.g., technical reports/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 and trade associations and track record in product clearance/registrations and regulatory advocacy.
- In depth knowledge and recognized for leadership & innovation in managing regulatory submissons to FDA, EPA or Canadian authorities.
- Successfully implemented complex/controversial regulatory policies and strategies, and/or systems to improve regulatory data communication.
- Demonstrated forming influence on the department (can be in non-technical/scientific manner) and/or strong impact on the success of future products 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 an employee-driven work culture.
- Competency in computer/software tools sufficient for the role and of systems needed to manage regulatory knowledge and submissions.
- Demonstrated ability to work effectively in a fast-paced team driven environment.
- Demonstrated continuous learning mindset and flexibility to expand expertise into new industries, applications, and jurisdictions.
Minimum Education Required:
BS/MS in biochemistry, biology, toxicology, regulatory, or applied sciences such as animal nutrition or food science. Ph.D. preferred.