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Senior Manager, Regulatory Affairs, North America

DuPont Industrial Biosciences

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Location: Palo Alto, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: EN-04704 Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description

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 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.

To extend our Industrial Biosciences’ Regulatory team, we are looking for:

Senior Manager, Regulatory Affairs, North America

We are currently seeking an outstanding individual to join our US-based Industrial Biosciences Product Stewardship & Regulatory Team.

Location: Palo Alto, California.

The primary responsibilities for this position include:
•Represent department in projects or product development teams, evaluate implications of product and process changes, and advise on regulatory implications of options and regulatory paths for product clearance. Prepare and or oversee compilation of dossier submissions
•Lead Palo Alto-based team, managing North American regulatory clearance and/or compliance for multiple, complex and/or strategically important areas
•Exercise judgment within broadly defined practices and policies in determining regulatory strategies for his/her areas of responsibility
•Define approaches and procedures on new assignments and provide guidance to other personnel
•Continuously assess the regulatory landscape and changes in DuPont Genencor science, and what is needed for the company in relation to this; implementation of any needed changes
•Influence regulatory/product stewardship policy both internally and externally
•Translate goals of the company into a strategic plan for his/her areas of regulatory responsibility
•Responsible for communication of regulatory strategies and policies, and implementation

Requirements & competencies:
•BS/MS in life sciences or related field and 10+ years experience in (industrial biotechnology) regulatory affairs or related areas, or PhD with 6+ years experience
•Excellent leadership and interpersonal and coaching skills to drive an employee-driven work culture
•Excellent communication (written and verbal) and people skills, attention to detail, ability to work with & lead teams
•In depth knowledge and recognized for leadership & innovation in at least one technical and regulatory area pertaining to DuPont Industrial Biosciences products
•Experienced in interaction with and education of regulatory agencies and trade associations to achieve clearance and positively influence regulations.
•Reasonable competency in computer/software tools needed for job and of systems needed to manage regulatory knowledge and submissions
•Proven track record of successful complicated submissions
•Successfully impacted product introductions by providing regulatory guidance and/or successfully influenced decisions at plants to implement change
•Successfully implemented complex/controversial regulatory policies and strategies, and systems to improve 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
•Successfully analyzed problems which require an in-depth understanding of the organization (problems often occur simultaneously and need prioritization)
•Demonstrated ability to work in a fast-paced team driven environment


To apply:
Please submit resumes to the “Jobs & Careers” section of our website at http://biosciences.dupont.com
Equal Opportunity Employer.

Requirements

Please see job description.
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