Top Regulatory Affairs Executive jobs in Hampton, VA

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Newport, 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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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Williamsburg, 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, Neurol...
  • 11 Days Ago

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Regulatory Specialist
  • Registrar Corp
  • Hampton, VA FULL_TIME
  • Regulatory Specialist Do you have a passion for research and providing exceptional customer service? Are you able to multitask and have strong problem-solving skills? Apply today to our Regulatory Spe...
  • 7 Days Ago

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Join our team
  • Top Guard Security
  • Hampton, VA FULL_TIME
  • JOIN OUR TEAM Armed & Unarmed Campus & Commercial Security Guards for Hampton, Newport News Looking to make a difference, or perhaps looking for a career then join us. Location : Top Guard Security 13...
  • 24 Days Ago

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ARE YOU ARMED DCJS CERTIFIED APPLY DCJS Quality Assurance Supervisor (Operations)
  • Top Guard Security
  • Hampton, VA FULL_TIME
  • Overview Do you hold an armed DCJS security License Then we have a grest opportunity for you. Join us. Top Guard Security is the leading security guard service provider for the Virginia Peninsula, the...
  • 3 Days Ago

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GREAT OPPORTUNITY APPLY NOW ARMED & UNARMED Roving Duty Officer - Hampton
  • Top Guard Security
  • Hampton, VA FULL_TIME
  • Overview Top Guard Security is seeking responsible individuals to conduct vehicle and/or foot patrol to secure client facilities and protect client’s employees, customers, tenants, and property from h...
  • 3 Days Ago

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0 Top Regulatory Affairs Executive jobs found in Hampton, VA area

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Aircraft Mechanic II
  • Yulista
  • Hampton, VA
  • Yulista Solutions LLC Regular Primary Function Provide maintenance on aircraft based at NASA Langley Research Center, Ha...
  • 3/28/2024 12:00:00 AM

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Diesel Fleet Technician III - Earn $30-$38/Hour + Benefits
  • Sysco
  • Hampton, VA
  • Sysco is Hiring a Diesel Fleet Technician III in Suffolk, VA! Earn $30-$38 per Hour* Plus an Annual Boot & Tool Allowanc...
  • 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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Plasma Center Assistant Manager Hampton, VA
  • Biolife Plasma
  • Hampton, VA
  • **Plasma Center Operations Leadership Opportunities** **Plasma Center Assistant Manager Hampton, VA** East Hampton, Virg...
  • 3/28/2024 12:00:00 AM

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District Support Pharmacist FT
  • CVS Health
  • Hampton, VA
  • Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to ever...
  • 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

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Experienced Collections Professional (VC)
  • Bill Gosling Outsourcing
  • Hampton, VA
  • Bill Gosling Outsourcing is committed to the career development of our people. If you are interested in joining a compan...
  • 3/25/2024 12:00:00 AM

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Immediate CNA positions Roanoke,Hampton, Virginia Beach, Chesapeake Bay, Portsmouth, VA
  • Trinity MedPro Staffing
  • Hampton, VA
  • About the job Immediate CNA positions Roanoke,Hampton, Virginia Beach, Chesapeake Bay, Portsmouth, VA Position Summary P...
  • 3/25/2024 12:00:00 AM

Hampton is an independent city in the Commonwealth of Virginia in the United States. As of the 2010 census, the population was 137,436. As one of the seven major cities that compose the Hampton Roads metropolitan area, it is on the southeastern side of the Virginia Peninsula. Hampton traces its history to the city's Old Point Comfort, the home of Fort Monroe for almost 400 years, which was named by the 1607 voyagers, led by Captain Christopher Newport, who first established Jamestown as an English colonial settlement. Since consolidation in 1952, Hampton has included the former Elizabeth City ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$276,608 to $452,547
Hampton, Virginia area prices
were up 1.2% from a year ago

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