Regulatory Affairs Manager jobs in Arkansas

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Rogers, AR 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.

  • 11 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Fort Smith, AR 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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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Jonesboro, AR 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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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Little Rock, AR 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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External Affairs Manager
  • Summit Utilities Inc
  • AR, US, AR FULL_TIME
  • Join our Growing Team and see why Summit Utilities, Inc was named as one of the Fastest Growing Denver Area Private Companies 2019 and 2020; Best Places to Work in Maine 2019, 2020, 2021, 2022 and 202...
  • 15 Days Ago

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Supply technician
  • Veterans Affairs, Veterans Health Administration
  • Little Rock, AR FULL_TIME
  • Summary The Central Arkansas Veterans Healthcare System consists of two inpatient campuses located at Little Rock and N. Little Rock, Arkansas. Little Rock is the capital of Arkansas, located in the c...
  • 28 Days Ago

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager (Chemical Labeling)
  • Astrix
  • Countryside, IL
  • The Regulatory Labeling Manager develops, coordinates, and implements regulatory strategies for products that require go...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Daikin Comfort
  • Waller, TX
  • Regulatory Affairs Manager Daikin Comfort Technologies Manufacturing, L.P. is seeking a skilled individual for our Regul...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 3/27/2024 12:00:00 AM

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Global Regulatory Affairs Manager II
  • Yoh, A Day & Zimmermann Company
  • Fort Worth, TX
  • Job Description Job Description Global Regulatory Affairs Manager II - Fort Worth 9 month contract W2 Pay Rate: $55.00 -...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Beacon Hill Staffing Group
  • San Fernando, CA
  • **Role is Fully Onsite to Northridge, CA** ROLE SUMMARY To support the our business in maintaining regulatory compliance...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Advanced Respiratory Technologies, Inc.
  • Pittsburgh, PA
  • Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Alameda Health System
  • Oakland, CA
  • Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditatio...
  • 3/25/2024 12:00:00 AM

Arkansas (/ˈɑːrkənsɔː/ AR-kən-saw)[c] is a state in the southern region of the United States, home to over 3 million people as of 2018. Its name is of Siouan derivation from the language of the Osage denoting their related kin, the Quapaw Indians. The state's diverse geography ranges from the mountainous regions of the Ozark and the Ouachita Mountains, which make up the U.S. Interior Highlands, to the densely forested land in the south known as the Arkansas Timberlands, to the eastern lowlands along the Mississippi River and the Arkansas Delta. Arkansas is the 29th largest by area and the 33rd...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$125,202 to $176,595

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019