Regulatory Affairs Specialist jobs in Shawnee, KS

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)

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Regulatory Affairs Specialist - Prelicense
  • CEVA Animal Health, LLC
  • Kansas, KS FULL_TIME
  • Regulatory Affairs Specialist - Prelicense

    Location: Lenexa, KS

    Job Summary and Purpose:



    The position is responsible for supporting the licensure of new vaccines and new label claims for Ceva Animal Health. The Pre-license RA Specialist will work with I&D to support licensing, provide regulatory information, and prepare submissions to the USDA to support new licenses and maintain existing licenses. Other responsibilities may include, but are not limited to, reviewing protocols and reports prior to submission to USDA to ensure these studies meet the regulatory requirements, completion of regulatory documents related to specific projects and supporting the RA Senior Specialist - prelicense in preparation of submissions. The RA Specialist will work with the project leader and R&D colleagues to help ensure timelines are met for submissions to the USDA.


    This position will stay up to date on new regulations to ensure license maintenance, compliance and product life cycle management guidelines are maintained.


    Responsibilities and Key Duties:


    • Support project team to progress projects, including drafting of regulatory tasks in accordance with the defined timelines
    • Draft and file submissions and responses to and from the USDA. Propose arguments and explanations to answer the questions and comments needed from the USDA for product licenses and life cycle management.
    • Update any applicable computer tracking systems (such as a document tracker or planned submissions database).
    • Keep track of documents needed for submission to USDA for licensure.
    • Build effective working relationships with colleagues.
    • Maintains awareness of regulatory practices, procedures, and changes, as appropriate by project.
    • Work on the implementation of compliance with current regulations (new memoranda from USDA) as directed.
    • Taking initiative to learn scientific innovation using multiple resources to expand skills and apply them.
    • Prepare/ write clear arguments and explanations in order to answer the questions and comments needed from the USDA for new product licenses.
    • Help evaluate the compliance of the analytical and clinical development plans with regulatory requirements of the USDA and their alignment with the specifications of each project.
    • Participate in project team meetings by assessing the regulatory requirements to achieve product approvals for new vaccines. Staying current with all regulatory related tasks and providing progress updates as needed.
    • Providing advice regarding the analytical and clinical study plans needed to support a new license.
    • Reviewing and reporting issues that should be addressed before documents are submitted to the USDA. Proposing corrective actions to minimize risk at submission.
    • Review and advise regarding the regulatory documentation before submission. .
    • Ensure that complete up-to-date records are maintained for compliance and guarantee of product integrity.
    • Support consistency and completeness of the technical regulatory documents for all submissions.

    Core Competencies and Attitudinal Characteristics:


    • Shape solutions out of complexity - Is open and curious of others perspectives
    • Client focus - Has in mind clients satisfaction
    • Collaborate with empathy - Has a positive attitude towards collaboration
    • Engage and develop - Clarifies short-term directions
    Drive ambition and accountability - Proactively manages own and others work
    Influence others - Communicates transparently

    Technical / Functional Competencies:


    • Ability to follow a strategy for authority submissions, and capacity to take corrective actions after identifying a risk. Demonstrates problem-solving attitude and be pro-active in their resolution.
    • Knowledge and know-how regarding regulatory requirements and guidelines, regulatory submission preparation, summary writing and licensure follow-up. High level of attention to detail.
    • Demonstrates good communication skills, both verbal and written. Ability to create presentations, internally and/or externally.
    • Ability to initiate, plan, prioritize, execute, control, and close the work of a team to achieve goals and meet specific success criteria at the milestones. Ability to work in a fast-paced environment and possess strong organizational skills to multi-task and prioritize multiple and diverse projects.
    • Ability to work independently.
    • Ability to master the tools & software related to the position.


    Qualifications:


    Education - Bachelor's degree in Veterinary, Biology, Microbiology or other science related field. Master's degree in Veterinary, Biology, Microbiology or other science related field preferred.


    Work Experience - Two or more years of experience in development, production or testing of veterinary biologics, including experience supporting veterinary biologics marketing authorizations.


    Other (consider certifications, specialized knowledge and/or training, etc.) - Knowledge of USDA regulations for veterinary biological products. Knowledge of biotechnology production a plus.

    Physical Requirements:


    • Must be able to read, write legibly and communicate in English
    • Tasks frequently require prolonged, mental and visual concentration

    Working Conditions:


    • Work can be remote, with time in the office as needed to ensure continued quality of work and as needed for team functions.

    Travel Required:


    • Up to 5% of time for business travel, including local, regional and international;


    This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

    • VEVRAA Federal Contractor

    **Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

    669B

  • 20 Days Ago

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FDA Post-Approval Regulatory Affairs Specialist
  • CEVA Animal Health, LLC
  • Kansas, KS FULL_TIME
  • FDA Post-Approval Regulatory Affairs Specialist Location: Lenexa, KS Job Summary and Purpose: The Regulatory Affairs Specialist is responsible for managing and documenting the routine regulatory activ...
  • 10 Days Ago

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Physical security specialist
  • Veterans Affairs, Veterans Health Administration
  • Leavenworth, KS FULL_TIME
  • Veterans Affairs, Veterans Health Administration Physical Security Specialist Leavenworth , Kansas Apply Now Summary This position serves as a vital part of the VA Police Services often serving as the...
  • 21 Days Ago

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Director of Public Policy & Regulatory Affairs - Remote
  • CRH
  • Overland Park, KS FULL_TIME
  • Job ID: 494321 Ash Grove Cement, a CRH company, provides Portland and masonry cements to help build the foundation and infrastructure for the world around us. We ship millions of tons of cement from o...
  • Just Posted

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Manager Regulatory Affairs Pre-Approval Pharma
  • CEVA Animal Health, LLC
  • Kansas, KS FULL_TIME
  • Manager Regulatory Affairs Pre-Approval Pharma Location: Lenexa, KS Job Summary and Purpose: Carryout and oversee regulatory activities to support the development, registration, and approval of new an...
  • 10 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Kansas, KS 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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0 Regulatory Affairs Specialist jobs found in Shawnee, KS area

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Regulatory Analyst I, II, or Senior (Relocate to Fayetteville, AR; Council Bluffs, IA; Lawrence, KS; or Rapid City, SD)
  • Black Hills Energy
  • Lawrence, KS
  • Regulatory Analyst I, II, or Senior (Relocate to Fayetteville, AR; Council Bluffs, IA; Lawrence, KS; or Rapid City, SD) ...
  • 3/28/2024 12:00:00 AM

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Registered Nurse Behavioral Health Emergency Department RN
  • Adventhealth Shawnee Mission
  • Shawnee, KS
  • Job Description All the benefits and perks you need for you and your family: n nn nn n Received Magnet recognition from ...
  • 3/28/2024 12:00:00 AM

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AVP, Deposits Risk
  • Synchrony Financial
  • Merriam, KS
  • Job Description: Role Summary/Purpose: This role will contribute to consumer compliance and operational risk oversight o...
  • 3/27/2024 12:00:00 AM

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Branch Manager.
  • Capitol Federal Savings Bank
  • Kansas City, KS
  • Job Description: Role Acts as sales manager for assigned staff members. Responsible for directing and administering the ...
  • 3/27/2024 12:00:00 AM

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Quality Compliance Team Leader
  • Colgate-Palmolive Company
  • Kansas City, MO
  • Site upgrade in progress. You will not be able to apply at this time. Please be patient and check back with us later. A ...
  • 3/27/2024 12:00:00 AM

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Strategic Finance and Operations Manager
  • backstitch
  • Kansas City, MO
  • The Role: We are in search of a Finance and Operations Manager who will support our needs as a scaling organization. Thi...
  • 3/26/2024 12:00:00 AM

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Workday Certified Prism Financial Reporting Manager
  • Accenture
  • Overland Park, KS
  • We are We are a global collective of innovators applying the New every day to improve the way the world works and lives....
  • 3/26/2024 12:00:00 AM

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Assistant Branch Manager - Platte-64th Street - Kansas City, MO
  • BNP Paribas Bank NV
  • Kansas City, MO
  • We are looking for **Assistant Branch Manager - Platte-64th Street - Kansas City, MO** **Location** At Bank of the West,...
  • 3/26/2024 12:00:00 AM

Shawnee /ʃɔːˈniː/ is a city in Johnson County, Kansas, United States. As of the 2010 census, the city population was 62,209. Shawnee is located at 39°0′46″N 94°45′57″W / 39.01278°N 94.76583°W / 39.01278; -94.76583 (39.012767, -94.765818). According to the United States Census Bureau, the city has a total area of 42.86 square miles (111.01 km2), of which, 41.85 square miles (108.39 km2) is land and 1.01 square miles (2.62 km2) is water. Shawnee Mission Park is a 1,600-acre (6.5 km2) park that includes a 120-acre (0.49 km2) lake....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$74,003 to $99,175
Shawnee, Kansas area prices
were up 1.7% from a year ago

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