Senior Regulatory Affairs Specialist (21890)
Provides regulatory support to meet department and corporate objectives for both on-going business and new product development. Work has primary emphasis on EPA Surface Sanitizer and Disinfectant products on a national and international level.
• Provides on-going, daily regulatory and technical support to R&D, Marketing, Sales, customers and others as needed.
• Creates Regulatory timelines and integrated development timelines
• Implements GCP and GLP to all development programs
• Manages projects to completion.
• Proactively provides updates on regulatory changes.
• Actively participates in trade association committees, which support company business needs and strategies.
• Participates in proactive efforts to influence emerging legislation. Forms, leads, participates in project teams.
• Researches complex regulatory issues and provides guidance to entire organization.
• Conducts the copy review of labels, labeling and graphics, in accordance with regulatory requirements.
• Researches relevant regulatory requirements for antimicrobial pesticide development phases
• Provides regulatory support for GLP safety testing, GLP efficacy testing, GLP product chemistry testing, GLP protocol development and overall Good Laboratory Practice adherence.
• Creates and applies documentation and control systems as required for regulatory areas.
• Verifies correct and up to date ingredient lists for all finished goods, in all required languages.
• Writes sections and complete dossiers for EPA pesticide registration submission.
• Provides guidance to development teams on appropriate content and format of submission deliverables.
• Compiles EPA Briefing Packages.
• Coordinates Agency Meetings.
• Conducts periodic regulatory strategy sessions
• Performs label, product, formulation and performance change control evaluation for regulatory impact.
• Establishes broad regulatory timelines and high level project management
• Applies regulations to business goals
• Handles regional registrations
• Responds to competitive threats and opportunities.
• Continuously improves work processes, productivity and accuracy of regulatory function.
• Tracks regulatory compliance as it relates to due dates.
• Communicates status and results to necessary and interested parties.
• This role may be tailored, to some extent, to fully utilize background and abilities.
• Other duties as assigned by manager and based on business needs.
BA/BS or higher technical degree required with two (2) to five (5) years direct or related regulatory background. Or, degree with three (3) to five (5) years direct or translatable experience in Quality Control/Assurance in EPA pesticide products, and/or specialty chemicals industry. Or, two-year degree with five (5) to seven (7) years experience in regulatory. Previous experience dealing directly with government regulatory agencies and personnel a plus.
Indirect management of support staff, some multidisciplinary project team leadership.
To apply for this position, please complete the online application process. You will have an opportunity to include your resume and a cover letter. GOJO is an Affirmative Action/Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability. Applicants must be lawfully authorized to work in the United States.
Recruiters, Search Agencies or others referring candidates to GOJO Industries, Inc. without written authorization from GOJO Industries, Inc. Human Resources will not be compensated in any way for their online referral even if GOJO Industries, Inc. hires the candidate. GOJO does not seek or respond to unsolicited resumes for positions that are not listed in the Careers section.
Job posted: 2020-07-13