Regulatory Affairs Manager jobs in Charleston, SC

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
  • Charleston, SC 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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Relationship Manager External Affairs
  • MUSC
  • Charleston, SC FULL_TIME
  • Job Description SummaryResponsible for the relationship development and management of a portfolio of assigned strategicpartnerships across MUSC’s tripartite mission. Identify, develop and maintain rel...
  • 1 Month Ago

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Senior Regulatory Compliance Engineer
  • Terracon Consultants, Inc.
  • Charleston, SC FULL_TIME
  • Job Description Are you looking for an Environmental Compliance Leadership Position? Do you thrive on challenges and want a position with advancement potential?Then explore our team as an Environmenta...
  • 22 Days Ago

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UNIV - Research Post Award Regulatory Specialist - HCC
  • Medical University of South Carolina Health System
  • Charleston, SC FULL_TIME
  • Job Description SummaryReporting to the Regulatory Quality Assurance and Education Manager, this position will be responsible for working closely with research sponsors in the handling of quality assu...
  • 17 Days Ago

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UNIV - Assistant Director of Alumni Affairs - Institutional Advancement
  • MUSC
  • Charleston, SC FULL_TIME
  • Job Description SummaryPosition Purpose:The Assistant Director of Alumni Affairs is part of Medical University of South Carolina (MUSC) Institutional Advancement Constituent Engagement Team and report...
  • Just Posted

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System Director Local Affairs and Economic Engagement
  • MUSC
  • Charleston, SC FULL_TIME
  • Job Description Summary see job description Entity University Medical Associates (UMA) Only Employees and Financials Worker Type Employee Worker Sub-Type Regular Cost Center CC001937 UMA OTHR PAY MUHA...
  • 2 Days Ago

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0 Regulatory Affairs Manager jobs found in Charleston, SC area

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Biomedical Equipment Support Specialist (Imaging)
  • U.S. Food and Drug Administration
  • Charleston, SC
  • ** Biomedical Equipment Support Specialist (Imaging)** **Department of Veterans Affairs** ** Ralph H. Johnson VA Medical...
  • 3/28/2024 12:00:00 AM

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Principal Medical Writer
  • MMS
  • Charleston, SC
  • MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,...
  • 3/28/2024 12:00:00 AM

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Transplant RN Coordinator- Adult Heart
  • Musc
  • Charleston, SC
  • Job Description Summary The Transplant RN Coordinator reports to the Transplant Program Manager of the Transplant Center...
  • 3/28/2024 12:00:00 AM

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Transplant RN Coordinator- Adult Heart/Lung
  • Musc
  • Charleston, SC
  • Job Description Summary The Transplant RN Coordinator reports to the Transplant Program Manager of the Transplant Center...
  • 3/28/2024 12:00:00 AM

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Veterinary Practice Manager
  • Animal Eye Care Associates
  • Charleston, SC
  • Job Description Job Description Animal Eye Care of the Lowcountry is looking for an experienced Practice Manager to join...
  • 3/28/2024 12:00:00 AM

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Research Specialist I
  • THENDOR THERAPEUTICS LLC
  • Charleston, SC
  • Job Description Job Description We are seeking a candidate who will assist our ongoing research directed toward understa...
  • 3/26/2024 12:00:00 AM

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Research Specialist I
  • THENDOR THERAPEUTICS LLC
  • Charleston, SC
  • Job Description Job Description We are seeking a candidate who will assist our ongoing research directed toward understa...
  • 3/25/2024 12:00:00 AM

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Operations Manager
  • Pacific Dental Services
  • Charleston, SC
  • Description: Now is the time to join a fast growing organization. You will have opportunities to learn new skills from o...
  • 3/25/2024 12:00:00 AM

Charleston is the oldest and largest city in the U.S. state of South Carolina, the county seat of Charleston County, and the principal city in the Charleston–North Charleston–Summerville Metropolitan Statistical Area. The city lies just south of the geographical midpoint of South Carolina's coastline and is located on Charleston Harbor, an inlet of the Atlantic Ocean formed by the confluence of the Ashley, Cooper, and Wando rivers. Charleston had an estimated population of 134,875 in 2017. The estimated population of the Charleston metropolitan area, comprising Berkeley, Charleston, and Dorche...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$130,469 to $184,025
Charleston, South Carolina area prices
were up 1.5% 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