Director- Regulatory Affairs- Strategic Projects Job

Job Title: Director- Regulatory Affairs- Strategic Projects
Functional Area: Legal & Regulatory Affairs
Division: Law & Regulatory Affairs
Location: Minnesota-St Paul
Country: United States
Employment Status: Full Time

Job Description:

The Director, Regulatory Affairs - Strategic Projects is responsible for developing regulatory strategy and providing project management leadership on key projects to support Ecolab's innovation in early stage product development (ideation/Phase 0/1). This newly created position will be global in scope and will support global product development projects, with emphasis on antimicrobial and handcare products. This leader will report directly to the Global Regulatory Affairs Vice President and will partner with Regulatory Affairs - Product Registration & Compliance and R&D product development teams to develop regulatory strategies that accelerate innovation in product development and commercialization. Working with external governmental agencies and academic thought leaders, the Director will influence outcomes of key product development and product registration projects. This is an exciting opportunity to be part of innovation and growth within a stable growing company. The successful candidate should expect to advance within the Regulatory or Research, Development and Engineering teams.
Main Responsibilities
·Direct development of global path to market strategy maps for product development of key product categories. Identify basic product registration and other regulatory requirements of major markets and assemble tools to support global product development.

·Develop and execute project plans for due diligence on key technology acquisition and licensing opportunities

·Develop and manage Project Management Office to support successful execution of regulatory support for key product development and product registration projects

·Manage consultants who may provide advice and support for product registration, due diligence, or other regulatory strategy projects

·Provide leadership and project management support to R&D, marketing, and other Ecolab units on key early stage technology projects and product registration requirements and other regulatory issues to facilitate speed to market of products. An important element of this is to develop product registration strategies that enable accelerated product development and successful execution of product registration by Ecolab's product registration & compliance staff around the globe who will not be reporting directly to this position.

·Support development of central information database about Ecolab's antimicrobial products to facilitate efficient global product development, perform ongoing review of R&D projects to assure product registration requirements of major markets are planned and executed to facilitate speed to market in major markets

·Develop systems and business processes to advise Ecolab senior management on a timely basis about regulatory agency inquiries and regulatory changes relating to product registrations, data requirements, and managing the costs of global registrations

·Develop strategy map of key relationships with governmental and academic thought leaders necessary to influence outcomes of key product development and product registration projects.

Basic Qualifications
·Bachelor's degree in chemistry, chemical engineering, biology, microbiology, toxicology, environmental sciences, and 12+ years of product development, product registration and regulatory affairs experience OR Advanced Degree and 10+ years of product development, product registration and regulatory affairs experience

·5+ years project management experience

·Immigration sponsorship not available for this role



Preferred Qualifications:

·PhD in chemistry, chemical engineering, biology, microbiology, toxicology, environmental sciences

·Experience dealing with global regulatory processes and EU Biocidal Products

·Directive (BPD), U.S. EPA, FDA, USDA, OSHA, DOT, and regulatory agencies outside the U.S

·Familiarity with regulatory requirements and standards governing global manufacturing and distribution of chemical , antimicrobial, and pharmaceutical products;

·Ability to represent the company in regulatory matters relating to product registration and environmental health issues;

·Ability to respond quickly in emergency situations relating to regulatory strategy issues, bearing in mind potential reporting requirements and public relations issues;

·Experience in training and teaching various personnel about regulatory requirements and practices;

·Experience with FIFRA-regulated pesticides, antimicrobial pesticides, food additives, topical antiseptic human drugs, and animal drugs.

AutoReqId 16063BR

Nearest Major Market: Minneapolis
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