Senior Regulatory Affairs Expert

Job Highlights

• Conduct activities including product registrations, registration reviews, and product expansions to align business strategies with EPA regulatory compliance.
• Interact with government agencies to advance regulatory agenda.
• Manage regulatory activities in California (e.g., CDPR, SB258, Prop 65).
• Manage regulatory activities for DIN registrations in Canada.
• Provide internal support to various functions within the business (Including Marketing, Supply Chain, Technical, and R&D).  Provide support for other regions on demand.
• Budget capital expenditures.
• MOC coordination.
• Oversight of quality assurance (e.g.,. Efficacy test monitoring).
• Coordinate and manage label review activities.
• Carry out management and create communication links with marketing and customer relations. 
• Review marketing material.
• Comply with training plan in order to acquire/improve new knowledge in the regulatory area and management skills.
• Develop expertise in FDA regulations (e.g., MoCRA); determine necessary level of engagement.
• Oversee activities related to Canadian registrations (e.g., PMRA, NNHPD).
• Support for unplanned activities and general compliance, such as label revisions, customer support, etc.

Requirements

• Bachelor’s Degree or equivalent in Biology, Chemistry, Chemical Biologist Pharmacy, Chemical Engineering or related field. 
• Working in a regulatory affairs, compliance or product stewardship field with active projects in antimicrobial or biocidal registrations (US/CAN).
• 5 -10 years of relevant experience.
• Effective communication, negotiation, good coordination activities, teamwork, collaboration, leadership, personal integrity, project administration, planning. Must be detail oriented, able to work independently and manage time effectively
• Strong ability to organize and prioritize multiple projects with competing deadlines while working in work in a high paced environment and able to change direction with little effort.
• Capable of easily and proactively collaborating with the business team, other functions and/or customers. 
• Deep knowledge of the regulatory activities such as dossier preparation and new product registration and providing support to customers-product registration.
• Experience in working with regulatory agencies or knowledge of areas of concentration such as: FDA, FIFRA (EPA), NNHPD (Health Canada), PMRA (Health Canada), and/or Pesticides/biocides.  Knowledge of policies and regulatory requirements including procedures and guidelines for registration of biocides by the US EPA, state agencies and Health Canada.
• Experience with regulatory dossier preparation, biocide product label development, and answering inquiries both from customers and regulatory authorities.
• This is a fully remote position and will be located in the United States.