Date Posted: 23 Jul 2010
Job Category:
Job TItle/Description: Director of Regulatory Affairs
Responsible for all facets of the company’s product and regulatory compliance programs. Provide regulatory leadership, strategy and guidance to executive management, technical, and business development staff. Ensures compliance with all state, federal and international regulatory statutes and laws. Maintain knowledge and understanding of all applicable international and domestic compliance regulations. Key regulatory strategy officer for the company.
 
Duties and Responsibilities
  • Supervise staff of 1-2 professionals.
  • Define and implement domestic and international regulatory strategies.
  • Work collaboratively with Executive, Business Development and Technical management to align regulatory strategy with overall business, commercial, brand and IP strategies.
  • Oversee, review and prepare the submission of all regulatory documents with EPA and international regulatory agencies.
  • Responsible for oversight of all aspects of regulatory submissions including data integrity and product performance claims.
  • Support and represent Company to regulatory authorities including the EPA and other regulatory agencies, including international agencies. Advises on necessary product or market actions as required for regulatory approvals and compliance.
  • Support new product development and existing product changes; provide guidance to product teams for regulatory pathway development, testing requirements, clarification, and follow up of submissions under review.
  • Develop and maintain effective relationships with regulatory agencies
  • Oversee and assist in the development and implementation of policies and procedures to facilitate communication and operational efficiency.
  • Support and integrate work within a structured quality system. Actively collaborate with Quality management in document control, label claims and approvals, document review, etc.
  • Develop and manage regulatory budget
  • Oversee outside regulatory counsel and advisors both domestically and internationally.
  • Advise Executive management on emerging regulatory issues and work closely with management on strategies to comply and benefit from emerging regulatory trends.
  • Work creatively and collaboratively with Marketing and Sales management on key product messaging and compelling value proposition language and claims while adhering to the letter and the spirit of the regulatory laws and framework.
 
Qualifications & Experience
  • Bachelor’s degree in chemistry, biology, microbiology, or other related science discipline.
  • Advanced science degree (MS or PhD) or law degree (JD) preferred
  •  10+ years direct compliance experience with EPA, TSCA, FIFRA
  • 5+ years supervisory experience
  • International pesticide regulatory experience strongly desired.
  • Experience developing regulatory strategies and assessments in collaboration with business teams
  • Experience in leading regulatory activities in a small to mid-size company, with the ability to learn and understand company and industry-specific issues and challenges.
  • Ability to communicate, train and educate effectively across functions and organizational levels
  • Extensive experience in direct dialogue and negotiation with EPA and similar authorities.
  • Experience collaborating with highly technical and scientific staff to achieve company goals
  • Understand critical technical issues and provide input to the technical team regarding regulatory strategies and priorities.
  • Integrate regulatory strategy with technical, commercial, and financial perspectives and communicate clearly with management, our partners, and outside entities.
  • High level of intelligence; ability to quickly grasp complicated technical issues and explain them in appropriately simplified terms
  • International business experience and cultural sensitivity
  • Good financial skills
  • Exceptional communication ad negotiation skills, with the ability to communicate effectively with partners, colleagues, operating managers, customers.
  • High degree of professionalism and cultural adaptability
  • Ability to work effectively in a matrixed organization – focusing on team success and individual accountability to broad/team-based results.
  • Proven ability to manage multiple priorities and projects, including the ability to make and meet commitments and deadlines.
  • Demonstrated leadership ability and future potential. 
  • Ability to work independently, as an individual contributor, and as a team-member of a broader strategic group.
  • Understanding (or willingness to learn fast) of the global drinking water market , key technologies, technology integration, products and market drivers
  • Strongly self-motivated
  • Computer proficient
  • Ability and desire to travel both domestically and internationally as needed (10-20%).