The Regulatory Manager, NA, reporting to the Regulatory Affairs Manager Latin and North America, is responsible for preparing, amending, and maintaining product registration dossiers for all product categories within Milk Quality and Animal Health (MQAH).
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 within Delaval.
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
Act as a technical writer in other regulatory compliance documents
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
Organic certification knowledge a plus
GLP and GMP knowledge a plus
Spanish language a plus
REQUIRED SKILLS / COMPETENCIES
Strong communication skills both in-person and in writing
Ability to handle multiple, competing priorities and projects
Computer literate and strong experience with MS Office, Access required
Ability to travel 10%
EXPERIENCE / BACKGROUND
S./B.A. with major courses in Chemistry, Biology, Biochemistry or Animal Sciences required
5+ years of experience in national or international regulatory affairs and/or compliance required
Strong experience with US FDA, EPA and Health Canada required
Experience in research and development desired
Previous experience and knowledge of requirements for product registrations in US, Canada and Mexico (for hygiene, feed additive and veterinary products) desired
Knowledge of regulatory requirements for detergents, sanitizers, veterinary drugs and feed additives desired
Knowledge of dairy production, in-vitro testing and clinical trials desired
We make sustainable food production possible.
DeLaval is a leading supplier of solutions that improve the performance of farms for professional food producers. 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 offer products, systems and services for all steps of milk produc...tion. Our solutions are used by millions of dairy farmers around the globe every day.
DeLaval was founded more than 125 years ago in Sweden, when the visionary Gustaf de Laval patented the cream separator. Today, DeLaval has 4500 employees and operates in more than 100 markets. DeLaval, alongside Tetra Pak and Sidel, is part of the Tetra Laval Group.