Regulatory Affairs Director jobs in Omaha, NE

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Associate Director, Regulatory Affairs
  • Merck Sharp & Dohme
  • Elkhorn, 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.

    We are seeking a Growth and Improvement minded Associate Regulatory Affairs Director that can help drive our Strategic Operating Priorities.

    • Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

    • Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

    • Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

    • Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

    • Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

    Summary, Focus and Purpose

    • The Associate Director Regulatory Affairs is a lead role responsible for managing direct reports and ensuring regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations.

    Key Functions

    • Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

    • Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and/or post license of US Biologicals | Serve as RA lead for designated R&D species and licensed products

    • Serve as an Alternate Liaison with the USDA for pre and/or post-regulatory responsibilities to include submissions and communications with the USDA, internal company departments and international permittees | Communicate as appropriate to direct in line manager communications or concerns

    • Review and prepare regulatory submissions in support of new licenses or licensed biologicals with the USDA | Prepare Standard International Dossiers and review registration documents for export markets where applicable

    • Supervise direct report personnel with priorities, development and performance management

    Education:

    • Bachelor’s degree with a minimum of 10 years of regulatory experience, or Master’s degree with a minimum of 5 years of regulatory experience in the vaccine or pharmaceutical industry.

    Requirements:

    • Strong working knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines. Leadership role to manage projects and direct reports, communicate interdepartmental teams and escalate communications when needed.

    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 separationpackage, 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:

    No

    Hazardous Material(s):

    N/A


    Requisition ID:
    R286951

  • Just Posted

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Omaha, NE FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Regulatory Affairs Intern
  • National Indemnity Company
  • Omaha, NE INTERN
  • Company:BHHIC Berkshire Hathaway Homestate Insurance CompanyAs a member of the Berkshire Hathaway group of insurance companies, we offer outstanding opportunities for professionals interested in worki...
  • Just Posted

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Regulatory Affairs Analyst
  • National Indemnity Company
  • Omaha, NE FULL_TIME
  • Company:BHHIC Berkshire Hathaway Homestate Insurance CompanyAs a member of the Berkshire Hathaway group of insurance companies, we offer outstanding opportunities for professionals interested in worki...
  • 15 Days Ago

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Architect - Associate Director of Planning, Design & Construction
  • Associate Director of Planning, Design & Construction - Creighton University Careers
  • Omaha, NE FULL_TIME
  • Qualifications: Requires a bachelor’s degree in Architecture or related field. Minimum 7 years of experience in project management, scheduling, cost estimating and construction contract administration...
  • 21 Days Ago

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Medical support assistant
  • Veterans Affairs, Veterans Health Administration
  • Omaha, NE FULL_TIME
  • Summary The Intermittent Medical Support Assistant functions as serving as an initial point of contact for the units, clinics, patient, to include, but not limited to, scheduling patient appointments,...
  • 21 Days Ago

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0 Regulatory Affairs Director jobs found in Omaha, NE area

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Pharmacy Department Manager
  • Hy-Vee, Inc.
  • Omaha, NE
  • At Hy-Vee our people are our strength. We promise "a helpful smile in every aisle" and those smiles can only come from a...
  • 3/28/2024 12:00:00 AM

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Director of Operations Property Management
  • NEBRASKA LIFESTYLES LLC
  • Omaha, NE
  • Job Description Job Description Benefits: Bonus based on performance Competitive salary Dental insurance Paid time off S...
  • 3/28/2024 12:00:00 AM

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Day Shift Warehouse Manager
  • US Foods, Inc.
  • Omaha, NE
  • ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for development of Day Warehouse Supervisors through training on poli...
  • 3/27/2024 12:00:00 AM

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Pharmacy Department Manager
  • Hy-Vee
  • Omaha, NE
  • At Hy-Vee our people are our strength. We promise "a helpful smile in every aisle" and those smiles can only come from a...
  • 3/27/2024 12:00:00 AM

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Director of Operations Property Management
  • NEBRASKA LIFESTYLES LLC
  • Omaha, NE
  • Job Description Job Description Must have extensive experience in Property Management at a high level. Regional Managers...
  • 3/27/2024 12:00:00 AM

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Certified Pharmacy Technician
  • Hy-Vee
  • Omaha, NE
  • At Hy-Vee our people are our strength. We promise "a helpful smile in every aisle" and those smiles can only come from a...
  • 3/26/2024 12:00:00 AM

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Solid Waste Facilites Practice Lead
  • HDR
  • Omaha, NE
  • About Us At HDR, we specialize in engineering, architecture, environmental and construction services. While we are most ...
  • 3/25/2024 12:00:00 AM

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Day Shift Warehouse Manager
  • The Judge Group
  • Omaha, NE
  • ARE YOU A CURRENT US FOODS EMPLOYEE? PLEASE APPLY DIRECTLY THROUGH OUR INTERNAL WORKDAY CAREER SITE. Join Our Community ...
  • 3/25/2024 12:00:00 AM

Omaha (/ˈoʊməhɑː/ OH-mə-hah) is the largest city in the state of Nebraska and the county seat of Douglas County. Omaha is located in the Midwestern United States on the Missouri River, about 10 miles (15 km) north of the mouth of the Platte River. The nation's 40th-largest city, Omaha's 2018 estimated population was 466,061. Omaha is the anchor of the eight-county, bi-state Omaha-Council Bluffs metropolitan area. The Omaha Metropolitan Area is the 59th largest in the United States, with an estimated population of 944,316 (2018). The Omaha-Council Bluffs-Fremont, NE-IA Combined Statistical Are...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$159,344 to $226,940
Omaha, Nebraska area prices
were up 0.8% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020