Top Regulatory Affairs Executive jobs in South Burlington, VT

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
  • Burlington, VT 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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Coordinator, Accreditation and Regulatory Affairs (RN)
  • The University of Vermont Medical Center
  • Burlington, VT FULL_TIME
  • Under the leadership of the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the implementation of the organizations regulatory program to assure...
  • 28 Days Ago

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Coordinator, Accreditation and Regulatory Affairs (RN)
  • University of Vermont Medical Center
  • Burlington, VT FULL_TIME
  • Job Details Job Ref:R0062342 Category:Registered Nurse Employment Type:Full Time Health Care Partner:The University of Vermont Medical Center Location:1 S Prospect, Burlington, VT Department:Regulator...
  • 1 Month Ago

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Coordinator, Accreditation and Regulatory Affairs (RN)
  • JobRapido
  • burlington, VT FULL_TIME
  • JOB DESCRIPTION:Under the leadership of the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the implementation of the organizations regulatory p...
  • 1 Month Ago

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Coordinator, Accreditation and Regulatory Affairs - RN
  • The University of Vermont Health Network
  • Burlington, VT FULL_TIME
  • JOB DESCRIPTION:Under the leadership of the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the implementation of the organizations regulatory p...
  • 1 Month Ago

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Director of Finance
  • Regulatory Assistance Project
  • Montpelier, VT FULL_TIME
  • POSITION: DIRECTOR OF FINANCE Location Remotely from a home office with regular trips to the Montpelier HQ office, as needed. Supervisory Responsibilities Supervises the accounting team members. Repor...
  • 26 Days Ago

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0 Top Regulatory Affairs Executive jobs found in South Burlington, VT area

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Staff Data Scientist, Risk Interventions
  • Stripe, Inc.
  • South Burlington, VT
  • Who we are About Stripe Stripe is a financial infrastructure platform for businesses. Millions of companies - from the w...
  • 3/28/2024 12:00:00 AM

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Medical Staff Quality & Data Specialist
  • The University of Vermont Medical Center Inc
  • South Burlington, VT
  • Building Name: UVMMC - 725 Community Drive Location Address: 725 Community Drive, South Burlington Vermont Regular Depar...
  • 3/28/2024 12:00:00 AM

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Sr. Account Executive, Middle Market (VT hybrid or EST remote)
  • NFP
  • South Burlington, VT
  • Who We Are NFP is a seven-time Best Places to Work award winner in Business Insurance who has also earned the 5-Star Div...
  • 3/28/2024 12:00:00 AM

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Management Trainee
  • Kinney Drugs
  • Burlington, VT
  • Overview: Scope of Responsibilities: Provides direct supervision to store employees in the absence of Store Manager. Ass...
  • 3/28/2024 12:00:00 AM

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Central Sterile Reprocessing Instrument Coordinator
  • The University Of Vermont Medical Center
  • Burlington, VT
  • JOB DESCRIPTION: The Central Sterile Reprocessing (CSR) Instrument Coordinator manages and administers scope (rigid and ...
  • 3/28/2024 12:00:00 AM

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Supervisory Production Controller (aircraft)
  • Department of the Air Force
  • South Burlington, VT
  • Summary THIS IS A NATIONAL GUARD TITLE 32 EXCEPTED SERVICE POSITION. This National Guard position is for a Supervisory P...
  • 3/26/2024 12:00:00 AM

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Industrial Hygiene Technician
  • Department of the Air Force
  • South Burlington, VT
  • Summary THIS IS A NATIONAL GUARD TITLE 32 EXCEPTED SERVICE POSITION. This National Guard position is for an Industrial H...
  • 3/25/2024 12:00:00 AM

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Senior Archaeologist/Cultural Resources Manager
  • VHB
  • South Burlington, VT
  • Overview: ABOUT THE POSITION Senior Archaeologist/Cultural Resources Manager | Hybrid | Vermont VHBs growing South Burli...
  • 3/24/2024 12:00:00 AM

South Burlington is a city in Chittenden County, Vermont, United States. As of the 2010 U.S. Census the population of the city was 17,904. It is home to the headquarters of Ben & Jerry's and Vermont's largest mall, the University Mall. It is also one in the principal municipalities of the Burlington, Vermont metropolitan area. Vermont's largest airport, Burlington International Airport, is located in South Burlington. Located in western Chittenden County, South Burlington is bordered by the municipalities of Burlington to the northwest, Winooski and Colchester to the north, Essex to the northe...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$288,262 to $471,613
South Burlington, Vermont area prices
were up 1.6% from a year ago

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