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Regulatory Affairs Specialist jobs in Nebraska

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

Recently Added Regulatory Affairs Specialist jobs

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Sr. Specialist, Regulatory Affairs
  • 3082 Intervet Inc. USA
  • Nebraska, NE FULL_TIME
  • Job Description Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Animal Health (AH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally. Our company's Animal Health, Elkhorn, NE is a BioTechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals. As a member of the Regulatory Affairs Biologics team, the Senior Specialist is responsible but is not limited to the following duties: Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals. Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA. Alternatively, may review and prepare registration documents for export markets. Review market advertising and promotions for US biologicals in compliance with USDA regulations. Prepare and maintain regulatory documents and communications regarding US biological products with local and federal agencies. Education: Minimum Requirements Bachelor’s degree with at least 5 years of USDA or FDA regulatory experience, -OR - Master’s degree with a minimum of 3 years of USDA or FDA regulatory experience in the vaccine or pharmaceutical industry. Knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines. Excellent time and project management skills. Excellent people, communication and leadership skills for involvement with cross departmental teams. #EBRG NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply 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 access 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 your job is to call on external stakeholders who require vaccination to enter 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, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here 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. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, 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: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts 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 presence. 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 collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the 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”. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 06/12/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
  • 4 Days Ago
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Regulatory Affairs Intern - Auto
  • BHHIC Berkshire Hathaway Homestate Insurance Company
  • Omaha, NE INTERN
  • Company: BHHIC Berkshire Hathaway Homestate Insurance Company As a member of the Berkshire Hathaway group of insurance companies, we offer outstanding opportunities for professionals interested in wor...
  • 4 Days Ago
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Regulatory Compliance Specialist
  • Hamilton Telecommunications
  • Aurora, NE FULL_TIME
  • Hamilton Telecommunications in Aurora, NE is seeking a highly motivated Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong understanding of regulatory compliance...
  • 21 Days Ago
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Lead Public Affairs Specialist
  • U.S. Department of the Treasury
  • Grand Island, NE FULL_TIME
  • DutiesWHAT IS THE TAXPAYER SERVICES DIVISION?A description of the business units can be found at: https://www.jobs.irs.gov/about/who/business-divisionsVacancies Will Be Filled In The Following Special...
  • Just Posted
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Public Affairs Specialist
  • U.S. Department of the Treasury
  • Lincoln, NE FULL_TIME
  • DutiesWHAT IS THE TAXPAYER EXPERIENCE DIVISION?A description of the business units can be found at: https://www.jobs.irs.gov/about/who/business-divisionsVacancies Will Be Filled In The Following Speci...
  • Just Posted
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Public Affairs Specialist
  • U.S. Department of the Treasury
  • Grand Island, NE FULL_TIME
  • DutiesWHAT IS THE TAXPAYER EXPERIENCE DIVISION?A description of the business units can be found at: https://www.jobs.irs.gov/about/who/business-divisionsVacancies Will Be Filled In The Following Speci...
  • Just Posted
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Regulatory Affairs Specialist jobs at Popular Companies

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Regulatory Affairs Specialist
  • Net2Source Inc.
  • Palo Alto, CA
  • Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
  • 6/2/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • ProKatchers LLC
  • Andover, MA
  • Job Summary: include specific internal and external relationships, product focus, regulatory requirements, physical dema...
  • 6/2/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • Idaho State Job Bank
  • Boise, ID
  • Regulatory Affairs Specialist at J&J Family of Companies in Boise, Idaho, United States Job Description Regulatory Affai...
  • 6/2/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • Alphatec Spine
  • Carlsbad, CA
  • Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
  • 6/1/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • TalentBurst, an Inc 5000 company
  • Fort Worth, TX
  • Position: Regulatory Affairs Specialist III, Req#: 2797-1 Location: Fort Worth, TX (100% Onsite) Duration: 6+ Months Con...
  • 5/31/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • CM Medical Recruitment
  • CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
  • 5/29/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • Cypress HCM
  • San Diego, CA
  • Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical informa...
  • 5/29/2024 12:00:00 AM
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Regulatory Affairs Specialist
  • Chromatech Inc. & B.V.
  • Canton, MI
  • At Chromatech, we create color solutions in a wide variety of markets around the globe. You can become part of our Chrom...
  • 5/29/2024 12:00:00 AM
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About Nebraska

The state is bordered by South Dakota to the north; Iowa to the east and Missouri to the southeast, across the Missouri River; Kansas to the south; Colorado to the southwest; and Wyoming to the west. The state has 93 counties and is split between two time zones, with the state's eastern half observing Central Time and the western half observing Mountain Time. Three rivers cross the state from west to east. The Platte River, formed by the confluence of the North Platte and the South Platte, runs through the state's central portion, the Niobrara River flows through the northern part, and the Rep...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$71,732 to $96,132

Most Popular Cities in Nebraska for Regulatory Affairs Specialist Jobs

What does a Regulatory Affairs Specialist do?

Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019