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Regulatory Affairs Director Job Code: 4760 POSTED: Sep 21 Salary: Open Location: Akron, Ohio Employer: GOJO Industries, Inc. Type: Full Time - Experienced Sector: Private Industry Discipline: Quality/Risk Management Required Education: 4 Year Degree ? ?

About GOJO Industries, Inc. GOJO is the leading global producer and marketer of skin health and hygiene solutions for away-from-home settings. Our broad portfolio includes hand cleaning, handwashing, hand sanitizing and skin care formulas under the GOJO?, PURELL? and PROVON? brand names. GOJO formulas use the latest advances in the science of skin care. In addition to gentle, effective formulas, GOJO is known for reliable dispensing technology, engineered with attention to aesthetics and functionality, plus complete progra....more info View all our jobs

Primary Responsibilities/Accountabilities Provides strategy, direction, and on-going management for the Regulatory Affairs team to further enterprise objectives. Work has primary emphasis on cosmetics and OTC drugs on a national and international level. Market Leadership? Corporate innovation and growth through support for market and product development.? Proactive response to business opportunities and threats. Quality Responsive, accurate, global regulatory support for GOJO products and customers. Continuous improvement of cost, quality, and performance of current services and business processes. Key Job Duties:? Sets strategy and direction for the Regulatory Affairs function in alignment with Enterprise objectives Achieves and maintains all required ingredient, product, and facility registrations and certifications Provides strategic direction, makes decisions and recommendations for regulatory submissions domestically and internationally Coordinates Corporate and Global Region regulatory activities and processes Maintains up-to-date information of all relevant regulatory issues Proactively communicates regulatory changes and trends Recommends and influences courses of action in response to new and proposed regulations Responds to competitive threats and opportunities Participates in proactive efforts to influence emerging legislation Actively participates in trade associations that support company business needs and strategies Provides regulatory technical support to R&D, Marketing, Sales, Supply Chain, customers and others as needed Proactively coordinates regulatory considerations into product design at an early development stage Identifies and assesses opportunities for competitive advantage through the regulatory arena Negotiates critical and controversial issues with company business leaders and regulatory authorities Insures alignment between regulatory and commercial timelines Cooperates with company business leaders in formulating and establishing global regulatory company policies, operating procedures and goals Creates regulatory strategies, processes and programs to advance the company Sustainability profile Communicates status and results to necessary and interested parties Directs, supervises, and coordinates activities of Regulatory Affairs team Creates and manages budget of Regulatory Affairs Develops direct reports through enhancement of skills, knowledge and abilities of individuals Creates and applies documentation and control systems as required for regulatory areas ?Continuously improves work processes, productivity and accuracy of regulatory function

Education and Experience Required BA/BS or higher technical degree with a minimum of eight (8) years of Regulatory experience in cosmetics, OTC drug industry. Previous experience dealing directly with government regulatory agencies and personnel. Regulatory Affairs Certification (RAC) preferred. Global regulatory experience highly preferred. Additional General/Technical Skills Required Must have knowledge of: Major regulatory aspects of skin care products, for both professional and consumer markets, including cosmetics, OTC, and new drugs Function, operation and interdependencies of research, marketing, quality assurance and manufacturing with the Regulatory Affairs function Process aligning technical resources to support business objectives and customer needs Technical knowledge in Regulatory Affairs and some aspects of Quality and Marketing/Customer Service Regulatory knowledge including the major regulatory aspects of skin care products, for both professional and consumer markets, both cosmetics and OTC Drugs Expert knowledge of the following: labeling; claims substantiation; MSDS; current Good Manufacturing Practices; OTC Drug Monographs; FDA; USDA, NSF,; TTB; and EPA regulations; National and state Food Codes; international product and establishment registration; VOCs, recycling, and biodegradability legislation; and any other pertinent regulatory and compliance issues at the local, state, national and international level Liability management; and customer problem-solving General or extendible knowledge in the formulation, microbiology, chemistry, toxicology, and packaging of a wide range of skin care products Interpretation of business risk and opportunity arising from regulatory issues and proactive generation of appropriate responses The regulatory process at local, state, national and international level Industry and trade groups with information/expertise in areas of responsibility and methods of accessing ?

Source: http://regulatorycareers.raps.org/jobs/4494664/regulatory-affairs-director

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