Top Regulatory Affairs Executive jobs in Gary, IN

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
  • Chesterton, IN 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.

  • 10 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Merrillville, IN 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...
  • 10 Days Ago

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Team Member
  • Tastee Top Grill
  • Cedar, IN PART_TIME,FULL_TIME
  • Looking for reliable individuals who are able to work in a fast paced environment. Duties include greeting customers, taking orders, preparing ice cream orders, light cleaning, etc. Day and evening sh...
  • 11 Days Ago

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Family Physician with Faculty
  • Top Tier Reps LLC
  • Valparaiso, IN FULL_TIME
  • Family Physician – Outpatient Primary CareWe are looking for a qualified physician to work a full time position in an outpatient community-based clinic. Our client has been around more than 30 years. ...
  • 16 Days Ago

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Mechanical Supervisor
  • Nationwide Technical & Executive Search
  • Portage, IN FULL_TIME
  • Mechanical Supervisor Portage, IN Onsite, Permanent, Full Benefits US Residents only, no sponsorships Relocation assistance available $80,000 - 95,000 The Supervisor of Mechanical Maintenance assists ...
  • 1 Day Ago

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Superintendent - Construction
  • Sandias Executive Search
  • Merrillville, IN FULL_TIME
  • Are you a Superintendent with expertise in ground-up and renovation projects for water and wastewater treatment plants? If so, we want to hear from you! With 20 years of experience, this $400M Midwest...
  • 1 Month Ago

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0 Top Regulatory Affairs Executive jobs found in Gary, IN area

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Water Quality & Environmental Compliance Specialist
  • American Water
  • Gary, IN
  • *Share Our Purpose. Be Yourself. Feel Valued.* People are the heart of our business. As an American Water employee, you ...
  • 3/28/2024 12:00:00 AM

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Travel Nurse RN - Med Surg / Telemetry - $2,298 per week
  • Adventist Health
  • East Chicago, IN
  • Vibra Travels is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in East Chicago, Indiana. Job D...
  • 3/28/2024 12:00:00 AM

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Travel Nurse RN - PCU - Progressive Care Unit - $2,298 per week
  • Adventist Health
  • East Chicago, IN
  • Vibra Travels is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in East Chicago, Indiana...
  • 3/28/2024 12:00:00 AM

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Travel Nurse RN - Med Surg - $2,298 per week
  • Adventist Health
  • East Chicago, IN
  • Vibra Travels is seeking a travel nurse RN Med Surg for a travel nursing job in East Chicago, Indiana. Job Description &...
  • 3/28/2024 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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Production Manager
  • Carmeuse North America
  • Gary, IN
  • The Production Manager is responsible for managing the workforce to ensure the production of lime meets or exceeds speci...
  • 3/27/2024 12:00:00 AM

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Quality Engineer (Pharmaceutical)
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Quality Assurance Engineer Department: Quality Reports To: Director of Regula...
  • 3/27/2024 12:00:00 AM

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RN-RENAL
  • Methodist Hospitals
  • Gary, IN
  • Overview: We are seeking a patient driven and highly motivated Registered Nurse to join our Renal Unit at Methodist Hosp...
  • 3/25/2024 12:00:00 AM

Gary is a city in Lake County, Indiana, United States, 25 miles (40 km) from downtown Chicago, Illinois. Gary is adjacent to the Indiana Dunes National Park and borders southern Lake Michigan. Gary was named after lawyer Elbert Henry Gary, who was the founding chairman of the United States Steel Corporation. The city is known for its large steel mills, and as the birthplace of the Jackson 5 music group. The population of Gary was 80,294 at the 2010 census, making it the ninth-largest city in the state of Indiana. It was a prosperous city from the 1920s through the mid-1960s due to its booming ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$292,016 to $477,755
Gary, Indiana area prices
were up 1.3% from a year ago

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