Regulatory Affairs Director jobs in Evansville, IN

Regulatory Affairs Director oversees regulatory matters and executes the 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 Regulatory Affairs Director 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, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Owensboro, KY 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
  • Evansville, 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...
  • 1 Day Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Carbondale, IL 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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Seeking Talented BC/BE Gastroenterologist for Wonderful Outpatient Practice Opportunity at the Marion IL VA Medical Center
  • Department of Veteran Affairs
  • Marion, IL FULL_TIME
  • Position Information: The Marion IL Veterans Affairs Medical Center is seeking a Board Certified / Board Eligible Gastroenterologist skilled in both upper and lower GI diagnostic and therapeutic proce...
  • 2 Months Ago

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Director
  • Drug and Alcohol Deferral Service (DADS)
  • Evansville, IN FULL_TIME
  • The Drug and Alcohol Deferral Service Director leads a court-based agency supervising approximately 400 client-defendants annually under Vanderburgh Misdemeanor Court. There are three separate tracks ...
  • 12 Days Ago

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Sales Director - Director of Admissions
  • Oakwood Health Campus
  • Tell, IN FULL_TIME
  • JOIN TEAM TRILOGY Trilogy Health Services is looking for the BEST sales professional. If you are BEST in sales, have a desire to represent a service that makes a difference, we want to talk to you! We...
  • 2 Months Ago

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0 Regulatory Affairs Director jobs found in Evansville, IN area

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Director of Nursing
  • Brickyard Healthcare
  • Evansville, IN
  • We rely on our Director of Nursing to plan, coordinate, and manage the nursing department. Why Work For Us? Excellent pa...
  • 3/19/2024 12:00:00 AM

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Client Service Specialist
  • Old National Bank
  • Evansville, IN
  • Overview: Old National Bank has been serving clients and communities since 1834. With $48 billion in total assets, we ar...
  • 3/18/2024 12:00:00 AM

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Residential/Community Specialist-FT Exempt
  • SIRS INC
  • Boonville, IN
  • Job Description Job Description Job Summary: This position is charged with ensuring quality in services provided to indi...
  • 3/18/2024 12:00:00 AM

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Internal Auditor
  • Harding Shymanski
  • Evansville, IN
  • Job Description Job Description Seeking an experienced Internal Auditor/ Compliance Associate with 2-5 years of experien...
  • 3/17/2024 12:00:00 AM

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Director of Clinical Excellence – RN
  • Brickyard Healthcare
  • Evansville, IN
  • The Director of Clinical Excellence – RN Develops, implements, and maintains a facility-wide infection prevention and co...
  • 3/15/2024 12:00:00 AM

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Internal Audit Manager
  • Harding Shymanski
  • Evansville, IN
  • Job Description Job Description Seeking an experienced Internal Auditor/Compliance Manager with 4-8 years of regulatory ...
  • 3/15/2024 12:00:00 AM

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Compliance Manager
  • Harding Shymanski
  • Evansville, IN
  • Job Description Job Description Seeking an experienced Internal Auditor/Compliance Manager with 4-8 years of regulatory ...
  • 3/15/2024 12:00:00 AM

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Compliance Associate
  • Harding Shymanski
  • Evansville, IN
  • Job Description Job Description Seeking an experienced Internal Auditor/ Compliance Associate with 2-5 years of experien...
  • 3/15/2024 12:00:00 AM

Evansville is a city and the county seat of Vanderburgh County, Indiana, United States. The population was 117,429 at the 2010 census, making it the state's third-most populous city after Indianapolis and Fort Wayne, the largest city in Southern Indiana, and the 232nd-most populous city in the United States. It is the commercial, medical, and cultural hub of Southwestern Indiana and the Illinois-Indiana-Kentucky tri-state area, home to over 911,000 people. The 38th parallel crosses the north side of the city and is marked on Interstate 69. Situated on an oxbow in the Ohio River, the city is of...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$159,298 to $226,875
Evansville, Indiana area prices
were up 1.3% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020