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Product Stewardship and Regulatory Senior Manager - United States
Dupont Biosciences (company)
Posted on : 04 April 2017
- Our company Industrial Bio sciences comprises an unmatched portfolio of capabilities in industrial biotechnology and bio based solutions.
- The unique combination of agricultural, biotechnology, chemical and material science capabilities allows our company Industrial Bio sciences to deliver cost-effective products with superior performance and sustainability aspects to a range of industries.
- Bringing together the expertise and our company has yielded a unique combination of strengths in enzyme technology, materials science, and bio processing.
- It’s what powers the innovations to help solve some of the world’s greatest challenges.
- Product Stewardship & Regulatory Manager / Sr. Manager – Animal Nutrition
- We are currently seeking an outstanding individual to join our Product Stewardship and Regulatory Team.
- Primary function: Global coordinator and North American regional support for animal feed and health product regulatory approvals and compliance program for
- Our company Industrial Bio sciences animal nutrition product portfolio, including probiotics and enzymes.
- Provide global strategic feed innovation & approvals coordination and advocacy support across industries and regions.
- Collaborate with individuals at varying company levels with global coordination focus.
- Interact with global business unit leadership, product managers, R&D, and the marketing team.
- Foster cohesion between the global and regional feed teams
- Liaise cross-regionally in the development and registration of new products
- Coordinate global project prioritization
- Coordination of global regulatory compliance for marketed IB products touching the feed industry, in conjunction with regional regulatory staff and product management supporting food industries
- Global focus on key trade associations across all regions; work with regional team leads on key company IB animal feed & health issues to ensure globally aligned positions.
- Identify and communicate changes in policy; coordinate global efforts across regions to influence national regulations in areas related to the Bio actives feed business through strong advocacy and leadership.
- Monitor globally for emerging trends, policies, regulations and guidance in animal feed & health; analyze and communicate regulatory intelligence
- Evaluate implications of product and process changes, and advise innovation teams and product management on regulatory implications of options and regulatory paths for product clearance of new IB product lines touching the animal feed/pet food industry.
- Prepare and/or oversee compilation of regulatory dossier submissions to North American Animal Feed authorities, in conjunction with global product stewardship & regulatory staff.
- Exercise judgment within broadly defined practices and policies in determining regulatory strategies for his/her areas of responsibility
- Continuously assess the regulatory landscape and changes in our company innovation, and what is needed for the company in relation to this; implementation of any needed changes
- 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
Minimum Education Required:
- BS/MS in animal nutrition or life sciences. PhD preferred.
General Competencies (years of experience: 8-12):
- Excellent leadership, 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 managing animal feed and/or animal health regulatory or similar program.
- Experienced in interaction with and education of regulatory agencies and trade associations and track record in product clearance/registrations and regulatory advocacy.
- Reasonable competency in computer/software tools needed for job and of systems needed to manage regulatory knowledge and 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 effectively in a fast-paced team driven environment
- Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents (e.g., technical reports/scientific papers).