Senior Specialist, US Regulatory Affairs in Rahway, NJ

Senior Specialist, US Regulatory Affairs - bolthires & Co. - Rahway, NJ - work from home job Company: bolthires & 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 animal science experience Knowledge of animal health product development Knowledge and understanding of the animal health sector NOTICE FOR INTERNAL APPLICANTS In accordance with reputed company subject to this policy are required to have a minimum of reputed company (12) months of service in reputed company position prior to applying for reputed company positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position reputed company the salary and geographical parameters as set forth in the reputed company Plan reputed company (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your reputed company or reputed company Advisor. Employees working in roles that reputed company determines require routine collaboration with external stakeholders, such as customer-facing reputed company, or research-reputed company, will be expected to reputed company not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to reputed company a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of reputed company is to call on external stakeholders who require vaccination to reputed company their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, reputed company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where reputed company determines in its discretion that the nature of the role presents an increased risk of disease reputed company. reputed company Employees apply reputed company Contingent Workers apply US and Puerto Rico Residents Only: reputed company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to reputed company innovation is reputed company diverse reputed company come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems reputed company. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a reputed company-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which reputed company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. Under reputed company, Colorado State, Washington State, and California State law, reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary reputed company: $97,680.00 - $153,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, reputed company holidays, vacation, and reputed company days. For Washington State Jobs, a reputed company of benefits is listed . Search Firm Representatives Please Read Carefully bolthires & Co., Inc., Rahway, NJ, USA, also reputed company as bolthires reputed company & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company bolthires / resumes submitted by search firms to any employee at reputed company without a valid written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation reputed company Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Senior Specialist, US Regulatory Affairs - bolthires & Co. - Rahway, NJ - work from home job Expected salary: $97680 - 153700 per year Location: Rahway, NJ Senior Specialist, US Regulatory Affairs - bolthires & Co. - Rahway, NJ - work from home job Job date: Sat, 26 Aug 2023 00:08:56 GMT Apply for the job now! Senior Specialist, US Regulatory Affairs - bolthires & Co. - Rahway, NJ - work from home job Apply tot his job Apply tot his job Apply To this Job