Senior Specialist, US Regulatory Affairs in Rahway, NJ

Senior Specialist, US Regulatory Affairs - reputed company & Co. - Rahway, NJ - work from home job Company: reputed company & Co. Job reputed company: Job reputed company We are seeking a reputed company and Improvement minded Senior US Regulatory Affairs Specialist that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising reputed company Science to Address Significant Unmet Medical Needs Execute | Prioritize Resources Behind Our Key reputed company Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our reputed company Business) Adapt | reputed company Our People, Culture and Business Model to reputed company with a Dynamic Landscape Diverse Talent | We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, reputed company workforce is critical to our ability to deliver reputed company to patients and customers around the world Values and Standards | Our Steadfast Dedication to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be reputed company to Our reputed company – They are a Competitive Advantage for Us reputed company, reputed company and Purpose The Senior Specialist US Regulatory Affairs position is accountable for maintaining the pesticide registrations and/or providing FDA submission support for labeling and reputed company, manufacturing, and controls (CMC) submissions and works as part of reputed company to prepare and submit marketed product reports to the regulatory authorities; maintains US state registrations, labeling, drug listings; the registration database; and the veterinary compendium; reviews and submits advertising and promotional labeling; obtains US Free Sales Certificates; submits three-day alerts and recall submissions. You may reputed company and support teams on various regulatory topics, optimize procedures, processes, infrastructure, assist with document management and offsite archiving as necessary, reputed company regular updates to management and escalates issues and you will report to the Director/Associate Directors of US Regulatory Affairs. Key Functions Work Independently and as reputed company member with reputed company | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion EPA Portfolio Management: Maintain the registered US pesticide products throughout their lifecycle which includes supporting label changes and extensions, reviewing advertising and promotional labeling and preparing notifications, amendments or other submissions as required by EPA FDA Submission Support: Submit post-approval CMC and Labeling submissions to FDA and assist with the archiving of the submissions, receive and reputed company communications from FDA reputed company to CMC and Labeling submissions and assist the Director with US 3-day alerts and Recall submissions Obtain documents from reputed company areas for inclusion in marketed product reports (e.g., periodic Drug Experience Reports, Quarterly Sales Reports and Antimicrobial Reports), prepare reports for submission (eSubmitter or hard copy) to regulatory authorities Maintain, monitor and approve reputed company versions and revisions reputed company to reputed company pharmaceutical and pesticide labeling for US marketed products Coordinate with the Director/Associate Directors, the review and submission of advertising and promotional labeling Maintain and update state registrations for reputed company assigned marketed products Build strong knowledge of federal and state regulations and guidance, as applicable and effectively convey information reputed company reputed company Maintain US drug listings, the registration database and the veterinary compendium Obtain Free Sales Certificates reputed company or participate on teams reputed company to regulatory topics and optimize processes, procedures and infrastructure Back-up Coordinator for offsite archiving of study documents and communicating reputed company documents are received by or shipped to external sites Provides regular updates to management and escalates issues. Other tasks or reputed company assigned Education Bachelor degree in a relevant discipline such as animal science, veterinary technology, immunology, toxicology/pharmacology, reputed company, biology, business, or regulatory with five years regulatory experience in the pharmaceutical industry, Or.... Master degree in a relevant discipline with three years regulatory experience. Required Regulatory and/or product development experience Principled verbal and written communication skills Excellent people, communication and leadership skills Proactive, organized, reputed company to manage time effectively and pay attention to detail Train and reputed company employees (i.e. US RA Specialists) to reputed company support needed to meet regulatory timelines Preferred Prior animal health regulatory experience Practical veterinary or Apply tot his job Apply To this Job