Sr. Regulatory Affairs Specialist

Mid to Senior level Regulatory Specialist position available -remote

Growth Opportunity !

Opportunity to work with a global company with a long history of providing sustainable food production products.

Fulltime opportunity available, great benefits, education benefits (seminars, continuing education, etc.), retirement ! Internal growth opportunities, several options within your career development.

10% travel within the United States

What we need:

• Someone with experience in product registrations (US & Canada)
• Interact with EPA, FDA, DEA
• Internal teams, R&D ,marketing, food processing plants, external clients
• Regulatory Specialist

Job Description:

We support our customers in reducing their environmental footprint while improving food production, profitability and the well-being of the people and animals involved.

We also supply food production facilities with needed cleaners, sanitizers and disinfectants that comply with EPA regulations.

The Regulatory Specialist, reporting to the Regulatory Affairs Manager Latin and North America, is responsible for preparing, amending, and maintaining product registration dossiers for all product categories

This role will work closely with the Regulatory Affairs Manager Latin America, Product Managers, R&D chemists and Sales team members and take on advanced Regulatory responsibilities as assigned. We are looking for someone who is a quick learner, a self-starter, and is confident to make recommendations/suggestions on regulatory issues in order to move the registration process along.

RESPONSIBILITIES

• Responsible for product registrations for North America including state and federal preparation submissions and maintenance of existing registrations, including amendments.

• Maintain regular contacts with Regulatory Authorities and regulatory consultants for the follow-up of dossiers, documentation or queries, related to veterinary topical products and hard surfaces detergents/disinfectants.

• Manage communications on needed data requirements for new and amended registrations

• Liaison with country specific consultants as required (may have specific country responsibility for registrations, etc.).

• Review/approve production documentation (i.e. formula, raw material monographs, test methods, etc.) particularly pertaining to product registration dossiers.

• Prepare and review clinical trial protocols and review final reports.

• Maintain all product registrations for compliance to US and Canada requirements.

• Respond to customers, government agencies and internal customer requests for regulatory information and emerging regulatory requirements.

• Develop and implement regulatory strategies to support business objectives.

• Evaluate label changes and marketing materials for regulatory compliance.

• Review and communicate any health, safety and environmental potential issues with company products.

• Determine, maintain FDA drug listings, registrations and other licenses.

• Research chemical compounds and Food Contact Notifications for R&D project development.

• Develop new labels and review current labeling for accuracy and completeness.

• Renew US EPA and State EPA product registrations.

• Develop/amend Safety Data Sheets and labels.

• May have cross-functional responsibilities with Quality Assurance with respect to product registrations and company compliance issues.

• Maintain good working relationships with various internal groups such as R&D, Product Management, Marketing, Sales, and Manufacturing.

• Work with global coworkers to help solve global regulatory and quality issues.

• Conduct ISO 17025 GLP quarterly audits.

• Author regulatory marketing and press releases to customers regarding regulatory impacts.

REQUIRED SKILLS / COMPETENCIES

• Organic certification knowledge a plus.

• GLP and GMP knowledge a plus.

• Ability to read and understand federal/state codes and other technical writings.

• Strong communication skills both in-person and in writing.

• Ability to handle multiple, competing priorities and projects.

• Able to manage projects and keep within timeline.

• Computer literate and strong experience with MS Office required.

EXPERIENCE / BACKGROUND

• B.S. degree in Chemistry, Toxicology, Biochemistry with additional course work in Animal Sciences preferred.

• Technical background required with 5+ years of direct laboratory experience and antimicrobial knowledge.

• Experience with US EPA, FIFRA, FDA (animal drugs and food contact) and Health Canada regarding new product registrations and label amendments in US, Canada and Mexico.

• Knowledge of regulatory requirements for detergents, sanitizers, disinfectants, and veterinary drugs desired.

• Knowledge of dairy production a plus and in-vitro testing and clinical trials desired.

• GLP experience highly desired.