Regulatory Affairs Specialist jobs in Norfolk, VA

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Norfolk, VA 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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Billing Specialist
  • Verdi Eye Specialist
  • Norfolk, VA FULL_TIME
  • Responsibilities:- Review and process medical billing claims- Verify accuracy of patient demographic and insurance information- Ensure compliance with coding and billing regulations- Resolve billing d...
  • 28 Days Ago

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Curatorial Affairs Administrative Coordinator
  • Chrysler Museum Of Art
  • Norfolk, VA FULL_TIME
  • Curatorial Affairs Administrative Coordinator Curatorial Affairs / Curatorial Director of Curatorial Affairs February 2024 Coordinates administrative activities related to the Collections & Exhibition...
  • 19 Days Ago

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Local Affairs Community Liaison
  • PETA
  • Norfolk, VA FULL_TIME
  • DescriptionPosition Objectives: We’re looking for a highly motivated person to drive PETA’s local outreach and public relations efforts to improve animal welfare – focusing primarily on “backyard” dog...
  • 1 Day Ago

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Fiscal Affairs Technician for Accounts Payable
  • Commonwealth of VA Careers
  • Norfolk, VA FULL_TIME
  • Title: Fiscal Affairs Technician for Accounts Payable Agency: VP OF ADMIN AND FINANCE Location: Norfolk, VA FLSA: Non-Exempt Hiring Range: Full Time or Part Time: Additional Detail Job Description:Thi...
  • 1 Day Ago

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Fiscal Affairs Technician for Accounts Payable
  • Old Dominion University
  • Norfolk, VA FULL_TIME
  • Posting Details Posting Details Working Title Fiscal Affairs Technician for Accounts Payable Position Number 00977A Department PARKING FACILITIES Location Norfolk, VA Type of Position Classified Type ...
  • 8 Days Ago

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0 Regulatory Affairs Specialist jobs found in Norfolk, VA area

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VP, Safety and Flight Compliance - UAS
  • DroneUp
  • Virginia Beach, VA
  • DroneUp, LLC was born out of a vision to make autonomous flight great for communities, great for business, and great for...
  • 3/28/2024 12:00:00 AM

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Personal Banker - Coliseum Mall
  • WELLS FARGO BANK
  • Hampton, VA
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/28/2024 12:00:00 AM

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Internal Revenue Agent (Examiner) - DIRECT HIRE (12 MONTH REGISTER) AMENDED
  • Department Of The Treasury
  • Norfolk, VA
  • Duties WHAT ARE THE APPEALS (AP), LARGE BUSINESS AND INTERNATIONAL (LB&I), SMALL BUSINESS SELF-EMPLOYED (SB/SE) AND TAX ...
  • 3/27/2024 12:00:00 AM

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Assistant Branch Manager
  • Langley Federal Credit Union
  • Virginia Beach, VA
  • ** Assistant Branch Manager** **Job Category****:** Branch Services **Requisition Number****:** ASSIS002071 Showing 1 lo...
  • 3/27/2024 12:00:00 AM

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Forward Hire Branch Manager - Southern Shores Store/NCCN District
  • WELLS FARGO BANK
  • Elizabeth City, NC
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Senior Vice President of Finance
  • Chartway Credit Union
  • Virginia Beach, VA
  • Job Title: Senior Vice President of Finance Job Type: Full-time Location: Virginia Beach, Virginia; Salt Lake City, Utah...
  • 3/26/2024 12:00:00 AM

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Personal Banker Little Neck Branch
  • WELLS FARGO BANK
  • Virginia Beach, VA
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Laborie Medical Technologies Corp
  • Portsmouth, VA
  • We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters ...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the city has a total area of 96 square miles (250 km2), of which 54 square miles (140 km2) is land and 42 square miles (110 km2) (43.9%) is water. Norfolk is located at 36°55′N 76°12′W / 36.917°N 76.200°W / 36.917; -76.200 (36.8857° N, 76.2599° W) The city is located at the southeastern corner of Virginia at the junction of the Elizabeth River and the Chesapeake Bay. The Hampton Roads Metropolitan Statistical Area (officially known as the Virginia Beach-Norfolk-Newport News, VA-NC MSA) is the 37th largest in the United States, with an estimated...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$71,278 to $95,523
Norfolk, Virginia area prices
were up 1.2% from a year ago

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In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
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Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
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The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
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