Regulatory Affairs Manager jobs in Fargo, ND

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
  • Fargo, ND 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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Program Manager - Facilities Regulatory & Life Safety
  • Essentia Health
  • Fargo, ND FULL_TIME
  • Job Description:This position will support facilities and plant operations in the development and management of applicable regulatory agency requirements, mainly related to life safety and the environ...
  • 1 Day Ago

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Business Affairs Generalist
  • ND State College of Science
  • Wahpeton, ND FULL_TIME
  • POSITION: Business Affairs Generalist LOCATION: NDSCS – Wahpeton, North Dakota TYPE OF APPOINTMENT: Full-time, 12-month, benefited position WHO MAY BE CONSIDERED: Anyone eligible to work in the United...
  • 24 Days Ago

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Food Safety, Quality and Regulatory Chemist (Sign on bonus)
  • OneTen
  • WAHPETON, ND FULL_TIME
  • Job Purpose and Impact The Quality Control Chemist, will provide expertise with all daily operations in quality control laboratories. In this role, you will support the buildup and maintenance of the ...
  • 1 Month Ago

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Manager
  • Minnesota
  • Menahga, MN FULL_TIME
  • Perks of Managing a Subway® : Monthly Bonus 3% IRA Match Start with 48 hrs. of Vacation / PTO in first year, increases every year. Free Food Flexible Scheduling Direct Communication with Local Owner A...
  • 3 Days Ago

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Manager
  • Subway - 45980-0
  • Menahga, MN FULL_TIME
  • Perks of Managing a Subway®:Monthly Bonus3% IRA MatchStart with 48 hrs. of Vacation/PTO in first year, increases every year.Free FoodFlexible SchedulingDirect Communication with Local OwnerAs part of ...
  • 12 Days Ago

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0 Regulatory Affairs Manager jobs found in Fargo, ND area

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Vice Chancellor for Information Technology/Chief Information Officer
  • Core Technology Services, North Dakota University System
  • Fargo, ND
  • Vice Chancellor for Information Technology/Chief Information Officer Position #: 00100340 # of positions: 1 LOCATION: Gr...
  • 3/29/2024 12:00:00 AM

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Warehouse Safety & Training Specialist
  • SpartanNash Company
  • Fargo, ND
  • At SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our sup...
  • 3/27/2024 12:00:00 AM

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APP - Physician Assistant or Nurse Practitioner | Electrophysiology
  • Sanford Health
  • Fargo, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/25/2024 12:00:00 AM

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APP - Physician Assistant or Nurse Practitioner | Urology
  • Sanford Health
  • Fargo, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/25/2024 12:00:00 AM

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APP - Physician Assistant or Nurse Practitioner | Pediatric Acute Wound Service
  • Sanford Health
  • Fargo, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/25/2024 12:00:00 AM

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APP - Physician Assistant or Nurse Practitioner | Nursing Home Care
  • Sanford Health
  • Fargo, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/25/2024 12:00:00 AM

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APP - Physician Assistant or Nurse Practitioner | Pain Clinic
  • Sanford Health
  • Fargo, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/25/2024 12:00:00 AM

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APP - Physician Assistant or Nurse Practitioner | Pediatric Neurology
  • Sanford Health
  • Fargo, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/25/2024 12:00:00 AM

Fargo is a core city of the Fargo-Moorhead metropolitan area, which also includes Moorhead, West Fargo, and Dilworth as well as outlying communities. Fargo sits on the western bank of the Red River of the North in a flat geographic region known as the Red River Valley. The Red River Valley resulted from the withdrawal of glacial Lake Agassiz, which drained away about 9,300 years ago. The lake sediments deposited from Lake Agassiz made the land around Fargo some of the richest in the world for agricultural uses. Fargo's largest challenge is the seasonal floods due to the rising water of the Red...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$128,897 to $181,808
Fargo, North Dakota area prices
were up 0.8% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020