Regulatory Affairs Manager jobs in Decatur, 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...
  • 20 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 Decatur, AL area

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Sonographer
  • VUEPOINT DIAGNOSTICS, LLC
  • Decatur, AL
  • VuePoint Diagnostics is a fast-growing mobile diagnostic company seeking a Sonographer in our Athens/Decatur area! The S...
  • 3/29/2024 12:00:00 AM

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Safety Systems Specialist
  • International Staffing Consultants, Inc.
  • Decatur, AL
  • The Safety Systems Specialist performs duties at the professional level in some or all of the following functional areas...
  • 3/28/2024 12:00:00 AM

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Supervisor- Warehouse Shift USA (A Crew/AM Shift)
  • FIRST SOLAR INC
  • Trinity, AL
  • First Solar reserves the right to offer you a role most applicable to your experience and skillset. Basic Job Functions:...
  • 3/28/2024 12:00:00 AM

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Quality Inspector 17.00/hr Start Immediately!!
  • Jobsource CH Alliance
  • Decatur, AL
  • Job Description Job Description Job Openings in Decatur, AL for a Quality Inspector Pay: 1st: $17.00 3rd: $17.50 Shift: ...
  • 3/28/2024 12:00:00 AM

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HR Manager
  • First Solar
  • Trinity, AL
  • Job Description Job Description Human Resources Manager The Human Resources Manager performs management-level strategic ...
  • 3/27/2024 12:00:00 AM

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Day Porter
  • ABM Industries, Inc.
  • Tanner, AL
  • Job Description Position Summary Details The Day Porter position provides the cleaning and upkeep of an assigned area. M...
  • 3/27/2024 12:00:00 AM

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Plant Engineer
  • Jobsource CH Alliance
  • Tanner, AL
  • Job Description Job Description We are seeking a Plant Engineer to become a part of our team! You will develop strategie...
  • 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

The Tennessee River has traditionally been the northern border of the city and Morgan County, but a small portion of the city extends across the river into Limestone County between U.S. 31 and I-65. Major bodies of water in the city include Wheeler Lake, Flint Creek, Lake Morgan, and Chula Vista Lake, all estuaries of the Tennessee River. The city does extend to the other side of Flint Creek and the Refuge in the Indian Hills and Burningtree subdivision areas. There is also an inlet that extends one mile (2 km) into the city limits from Wheeler Lake called Dry Branch.[citation needed] The nort...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$127,059 to $179,215
Decatur, Alabama area prices
were up 1.3% 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