Top Regulatory Affairs Executive jobs in Wisconsin

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
  • Madison, WI 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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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Green, WI 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...
  • 1 Day Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Menomonee Falls, WI 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...
  • 1 Day Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Milwaukee, WI 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...
  • 1 Day Ago

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Regulatory Affairs Specialist
  • Actalent
  • Neenah, WI OTHER
  • Description:To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, a...
  • 9 Days Ago

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Regulatory Affairs Specialist
  • Genus PLC
  • De Forest, WI FULL_TIME
  • Business Overview Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange. Genus PLC has a presence in over 7...
  • 1 Month Ago

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Senior Regulatory Affairs Specialist
  • LENSAR, Inc.
  • Orlando, FL
  • Company Overview LENSAR, Inc. is the leader in advanced femtosecond laser technology for refractive cataract surgery. Th...
  • 3/18/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Akkodis
  • Company: My client is a global leader and fast-growing manufacturer of instrumentation for Patient Monitoring, Sleep Ass...
  • 3/18/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Teleflex
  • Reading, PA
  • Date: Feb 21, 2024 Location: Wyomissing, PA, US Company: Teleflex Expected Travel: None Requisition ID: 9538 About Telef...
  • 3/18/2024 12:00:00 AM

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Regulatory Affairs Officer
  • Brio Group
  • Job Title: Regulatory Affairs Officer Company: Biopharma Organization Location: Hybrid, RTP Area Brio Resource Group is ...
  • 3/17/2024 12:00:00 AM

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Regulatory Affairs Specialist II
  • Cypress HCM
  • Overview: We're seeking a RA Specialist to provide support for products transitioning regulation standards within the me...
  • 3/17/2024 12:00:00 AM

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Regulatory Affairs Specialist (Mandarin)
  • Intepros Consulting
  • Exton, PA
  • IntePros is currently looking for a Regulatory Affairs Specialist with Mandarin experience to join one of premier medica...
  • 3/15/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Astrix Technology
  • Saint Paul, MN
  • Senior Regulatory Affairs Specialist Regulatory Affairs Saint Paul , MN, US Pay Rate Low: 41.88 | Pay Rate High: 47.85 +...
  • 3/15/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Careerbuilder
  • Bothell, WA
  • Verathon, Inc. Senior Regulatory Affairs Specialist Bothell , Washington Apply Now Senior Regulatory Affairs Specialist ...
  • 3/14/2024 12:00:00 AM

Wisconsin is bordered by the Montreal River; Lake Superior and Michigan to the north; by Lake Michigan to the east; by Illinois to the south; and by Iowa to the southwest and Minnesota to the northwest. A border dispute with Michigan was settled by two cases, both Wisconsin v. Michigan, in 1934 and 1935. The state's boundaries include the Mississippi River and St. Croix River in the west, and the Menominee River in the northeast. With its location between the Great Lakes and the Mississippi River, Wisconsin is home to a wide variety of geographical features. The state is divided into five dist...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$287,768 to $470,805

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