Regulatory Affairs Manager jobs in Huntsville, AL

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
  • Huntsville, AL 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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US E- Advisory – Manager - Contract Lifecycle Management (Icertis) - Regulatory &Legal Support
  • Deloitte US
  • Huntsville, AL FULL_TIME
  • Legal Business Services – Manager – Contract Lifecycle Management (Icertis)Deloitte Discovery’s Legal Business Services (LBS) teams provide a comprehensive suite of legal management consulting, inform...
  • 10 Days Ago

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Regulatory Compliance Analyst/Mgr
  • Sanmina Corporation
  • Huntsville, AL FULL_TIME
  • Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest growing segments of the global Electronics Manufacturing Services (EMS) market. Recogniz...
  • 27 Days Ago

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Alumni Affairs Coordinator
  • Alabama A&M University
  • Normal, AL FULL_TIME
  • Location: Normal, AL Category: Other Professional Posted On: Tue Oct 3 2023 Job Description: Summary: Acts as primary staff liaison to alumni, and all other constituencies to provide support for Alumn...
  • 19 Days Ago

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Public Affairs Specialist
  • Media Fusion
  • Huntsville, AL FULL_TIME
  • PCI Productions LLC has a passion for our team members and their personal mission for success. We offer excellent insurance, leave, and developmental benefits, along with some flexibility for remote w...
  • Just Posted

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Director of Alumni Affairs
  • Athens State University
  • Athens, AL FULL_TIME
  • Director of Alumni Affairs Athens State University Closing Date: Job Duties: The Director of Alumni Affairs reports directly to the Assistant Vice President of External and Alumni Affairs and is respo...
  • 1 Day Ago

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0 Regulatory Affairs Manager jobs found in Huntsville, AL area

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Public Affairs Specialist
  • Missile Defense Agency
  • Huntsville, AL
  • Summary This is a Direct Hire Authority (DHA) solicitation utilizing the DHA for Acq Demo Business and Technical Managem...
  • 3/28/2024 12:00:00 AM

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H&M Sales Associate
  • H&M
  • Huntsville, AL
  • Company DescriptionJob Description About the Role At H&M, as a Retail Sales Associate you will be advising our customers...
  • 3/28/2024 12:00:00 AM

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Internal Revenue Agent (Examiner) - (Temp NTE 1 Year, MBE, MBMP) 12 MONTH ROSTER (AMENDED)
  • Department Of The Treasury
  • Huntsville, AL
  • Duties WHAT IS THE SMALL BUSINESS/SELF EMPLOYED (SB/SE)DIVISION? A description of the business units can be found at: ht...
  • 3/27/2024 12:00:00 AM

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Operations Manager (2nd shift) - Facilities
  • Aramark Corp.
  • Huntsville, AL
  • Job Description The Operations Manager I will typically supervise entry-level employees and is responsible for leveragin...
  • 3/27/2024 12:00:00 AM

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Contracts and Compliance Officer
  • PeopleTec, Inc.
  • Huntsville, AL
  • Responsibilities: As a Contracts and Compliance Officer, you will play a vital role in ensuring that our organization ad...
  • 3/27/2024 12:00:00 AM

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Chief Engineer
  • Courtyard Huntsville University
  • Huntsville, AL
  • Job Summary: The Chief Engineer is responsible for ensuring proper operations maintenance service and repair of all equi...
  • 3/26/2024 12:00:00 AM

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Property Management Specialist Level 10
  • Gleason Research Associates, Inc.
  • Huntsville, AL
  • FLSA Classification: Non-Exempt ONSITE Job Duties and Responsibilities may include, but are not limited to: Maintains ac...
  • 3/25/2024 12:00:00 AM

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Program Support Senior Consultant (Strategic Acquisition) in Huntsville, AL (Secret cleared)
  • Deloitte
  • Huntsville, AL
  • Are you a creative thinker who loves to be on the cutting edge, solving problems though innovative technology solutions?...
  • 3/25/2024 12:00:00 AM

Huntsville is a city located primarily in Madison County in the Appalachian region of northern Alabama. Huntsville is the county seat of Madison County. The city extends west into neighboring Limestone County and south into Morgan County. Huntsville's population was 180,105 as of the 2010 census. Huntsville is the third-largest city in Alabama and the largest city in the five-county Huntsville-Decatur-Albertville, AL Combined Statistical Area, which at the 2013 census estimate had a total population of 683,871. The Huntsville Metropolitan Area's population was 417,593 in 2010 to become the 2n...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$131,384 to $185,315
Huntsville, Alabama area prices
were up 1.3% from a year ago

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