Regulatory Affairs Specialist jobs in Charleston, WV

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
  • Charleston, WV 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.

  • 1 Day Ago

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External Affairs Specialist
  • 748
  • Charleston, WV FULL_TIME
  • Share Our Purpose. Be Yourself. Feel Valued. People are the heart of our business. As an American Water employee, you will be offered a competitive salary and health benefits package, along with oppor...
  • 9 Days Ago

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Credentials Specialist 2 -- Medical Affairs -- General Hospital
  • CAMC Health System
  • Charleston, WV FULL_TIME
  • Adhere to and apply standards outlined in the CAMC Medical Staff Governing Documents to ensure all applications are processed in accordance with accrediting body and other regulatory standards. Valida...
  • 5 Days Ago

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Medical Staff Quality Specialist -- Medical Affairs -- General Hospital
  • Charleston Area Medical Center (CAMC) Health System
  • Charleston, WV FULL_TIME
  • Job Summary Support Vice President for Medical Affairs for provision of expertise and facilitation to elected Medical Staff leaders, Medical Staff committee chairs, and Clinical Directors for carrying...
  • 20 Days Ago

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Urologist, Beautiful Beckley Va Medical Center
  • Department of Veteran Affairs
  • Beckley, WV FULL_TIME
  • 1 license/50 States - 49 days paid time off annually - No Overhead or Insurance Company’s to deal with! Practice Pure MedicineAs a VA Urologist your possibility are endless! The Beckley VA Medical Cen...
  • 2 Months Ago

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Staff Radiologist, Outstanding Opportunity – Beckley, West Virginia
  • Department of Veteran Affairs
  • Beckley, WV FULL_TIME
  • 1 license/50 States - 49 days paid time off annually - No RVUs - Recruitment Incentives Great Quality of Life Come back home or make West Virginia your new home. We are one of the nation’s most beauti...
  • 2 Months Ago

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0 Regulatory Affairs Specialist jobs found in Charleston, WV area

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Clinical Research Coordinator -- Clinical Trials Center -- Memorial-MSOB
  • Charleston Area Medical Center
  • Charleston, WV
  • Job Summary Coordinates all aspects of clinical research trials. Assists in managing relationships with sponsors, physic...
  • 3/18/2024 12:00:00 AM

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Clinical Supervisor ($4000 Hiring Bonus)
  • Pressley Ridge
  • Charleston, WV
  • Be the change you wish to see in the world! Come join our team to empower children and families in our communities to tr...
  • 3/18/2024 12:00:00 AM

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Information Technology Manager -- IS Clinical Foundations -- Northgate-400 Association Dr.
  • CAMC Health System
  • Charleston, WV
  • Job Summary Provides leadership and management of the day-to-day operations of areas that include Network Infrastructure...
  • 3/18/2024 12:00:00 AM

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Transportation Finance Specialist - Direct Hire
  • Federal Highway Administration
  • Charleston, WV
  • Summary The incumbent serves as a Transportation Finance Specialist within the Federal Highway Administration, providing...
  • 3/18/2024 12:00:00 AM

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AMAP - Approved Medication Assistive Personnel- Pick your own shifts! Charleston, WV
  • KARE
  • Charleston, WV
  • Do You KARE? Join the KARE Revolution! Are you a licensed MEDICATION AIDE? Apply to be a HERO today. For more informatio...
  • 3/18/2024 12:00:00 AM

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Vice Chancellor for Academic Affairs
  • West Virginia Higher Education Policy Commission
  • Charleston, WV
  • Cabinet level position serving under the direction of the Chancellor(s), responsible for providing leadership and oversi...
  • 3/15/2024 12:00:00 AM

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Station Manager - CRW
  • Unifi
  • Charleston, WV
  • Essential Functions / Key Responsibilities Builds partnerships with customers and sets the example for the delivery of e...
  • 3/15/2024 12:00:00 AM

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Sr Financial Analyst
  • American Water
  • Charleston, WV
  • *Share Our Purpose. Be Yourself. Feel Valued.* People are the heart of our business. As an American Water employee, you ...
  • 3/14/2024 12:00:00 AM

Charleston is the most populous city in, and the capital of, the U.S. state of West Virginia. Located at the confluence of the Elk and Kanawha rivers, the population during the 2017 Census Estimate was 47,929. The Charleston metropolitan area as a whole had 214,406 residents. Charleston is the center of government, commerce, and industry for Kanawha County, of which it is the county seat. Early industries important to Charleston included salt and the first natural gas well. Later, coal became central to economic prosperity in the city and the surrounding area. Today, trade, utilities, governm...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$68,954 to $92,408
Charleston, West Virginia area prices
were up 1.2% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
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.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
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.
February 02, 2020