Top Regulatory Affairs Executive jobs in Kansas City, MO

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall 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 Top Regulatory Affairs Executive 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Kansas, MO 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, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

    Our approximately 7,000 employees are united around our mission of improving peoples lives with our health care products.

    The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs. The Executive Director is responsible for ensuring the pieces are in compliance with regulatory agencies requirements.

    Responsibilities:

    • Manages the Regulatory Promotional reviews for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products. This position may require reviewing promotional materials if the company requires it. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.

    • Provide guidance on proposed claims for products in development and development of ISI and brief summaries.

    • Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters. Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP) and other regulatory considerations that may impact business. Develop or revise procedures as needed.

    • Review packages for regulatory advice, resolution of FDA action letters and leads the company in discussions with OPDP.

    • Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products.

    • Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.

    • Interacts with Quality related to internal audits and CAPAs, as needed.

    Qualifications:

    • Bachelor Degree in science or health related discipline required (Advanced degree PhD, MD, MS, PharmD preferred)

    • 12 years of pharmaceutical experience with 10 years of regulatory affairs product advertising and promotion experience required.

    • GI experience strongly preferred

    • Broad knowledge of the pharmaceutical industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.

    • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency

    • Strong interpersonal skills with the ability to influence others in a positive and effective manner

    • Ability to work in a team environment

    • Working knowledge of Rx NDA development and approval process

    • Excellent communication skills; both oral and written

    As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 280K – 320K.

    Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

    This position may be available in the following location(s): [[location_obj]]

    We thank you in advance for your interest in growing and developing with Bausch Health. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.

    Any exception will have to be authorized by your HR Business Partner.

    Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

    If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

    To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .

    Bausch Health is an EEO/AA employer M/F/D/V.

  • 1 Day Ago

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Sales Executive
  • Top Closers
  • Blackburn, MO FULL_TIME
  • Are you looking for your next exciting career move in sales? Are you driven, self-motivated, and an excellent communicator? If the answer is YES, then look no further as this is the role for you! We h...
  • 6 Days Ago

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Field Sales Executive
  • Top Closers
  • Blackburn, MO FULL_TIME
  • Are you looking for your next exciting career move in sales? Are you driven, self-motivated, and an excellent communicator? If the answer is YES, then look no further as this is the role for you! We h...
  • 6 Days Ago

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Research Regulatory Affairs Spec
  • Children's Mercy KC
  • Kansas, MO OTHER
  • Thanks for your interest in Children's Mercy! Do you envision finding a meaningful role with an inclusive and compassionate team? At Children’s Mercy, we believe in making a difference in the lives of...
  • 11 Days Ago

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Sr. Regulatory Affairs Manager (Relocation to Kansas City, MO)
  • Strategic Staffing Solutions
  • Kansas, MO PART_TIME,CONTRACTOR,TEMPORARY
  • Job Title: Sr. Regulatory Affairs Manager Duration: Permanent / Full Time / Direct Hire Location: Kansas City, MO (HYBRID) – Relocation Assistance would be offered Pay: 110k-150k plus bonus ( Salary b...
  • 5 Days Ago

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Data Entry Administrator
  • Top Stack
  • Kansas, MO FULL_TIME
  • Job Description Job Description We are seeking a Data Entry Administrator to become an integral part of our team! This is a part time, contract position, and the hours will be 4pm - 8pm CST Monday thr...
  • 15 Days Ago

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0 Top Regulatory Affairs Executive jobs found in Kansas City, MO area

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Residency Coordinator
  • Truman Medical Centers
  • Kansas City, MO
  • **If you are a current University Health or University Health Physicians employee and wish to be considered, you must ap...
  • 3/18/2024 12:00:00 AM

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Enterprise Risk Management - Third Party Risk Manager
  • Dickinson Financial Corporation
  • Kansas City, MO
  • Position Description Summary: The Third-Party Risk Manager works under the supervision of the CRO/ERM and is primarily r...
  • 3/18/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Kansas City, MO
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 3/18/2024 12:00:00 AM

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Construction Inspector
  • TranSystems Corporation
  • Kansas City, MO
  • Overview: We are excited to share once again TranSystems has been recognized as a top 100 design firm by Engineering New...
  • 3/16/2024 12:00:00 AM

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Operations Finance Manager
  • TranSystems Corporation
  • Kansas City, MO
  • Overview: We are excited to share once again TranSystems has been recognized as a top 100 design firm by Engineering New...
  • 3/15/2024 12:00:00 AM

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Assistant Electrical Engineer - 1898 & Co. Energy & Utilities Consulting (Kansas City)
  • Burns & McDonnell
  • Kansas City, MO
  • **Description** The Assistant Electrical Engineer (or Energy & Utilities Analyst) will assist our clients by helping exe...
  • 3/15/2024 12:00:00 AM

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Assistant Electrical Engineer- 1898 & Co. Energy & Utilities Consulting (Kansas City)
  • Burns & McDonnell
  • Kansas City, MO
  • **Description** The Assistant Electrical Engineer (or Energy & Utilities Analyst) will assist our clients by helping exe...
  • 3/15/2024 12:00:00 AM

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EHS Specialist
  • AFL
  • Kansas City, MO
  • AFL provides industry-leading fiber optic products and services across the globe. Our company was founded in 1984 with a...
  • 3/15/2024 12:00:00 AM

Kansas City is the largest city in the U.S. state of Missouri. According to the U.S. Census Bureau, the city had an estimated population of 488,943 in 2017, making it the 37th most-populous city in the United States. It is the central city of the Kansas City metropolitan area, which straddles the Kansas–Missouri state line. Kansas City was founded in the 1830s as a Missouri River port at its confluence with the Kansas River coming in from the west. On June 1, 1850 the town of Kansas was incorporated; shortly after came the establishment of the Kansas Territory. Confusion between the two ensued...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$286,512 to $468,750
Kansas City, Missouri area prices
were up 1.7% from a year ago

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