Top Regulatory Affairs Executive jobs in Concord, NC

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
  • Charlotte, NC 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
  • Huntersville, NC 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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Director, Regulatory Affairs
  • Octapharma Plasma, Inc.
  • Charlotte, NC FULL_TIME
  • How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an Industry Leader [Become one, too!] Octapharma Plasma offers professional opport...
  • 19 Days Ago

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Senior Regulatory Affairs Specialist
  • Safeguard Medical
  • Harrisburg, NC FULL_TIME
  • DescriptionThe Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements for medical devices and pharmaceutical products.This position requires ...
  • 22 Days Ago

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Director, Regulatory Affairs
  • Default Board
  • Charlotte, NC FULL_TIME
  • How to Maximizeyour opportunity to do rewarding work,your future leadership potential,and your career growth? Join an Industry Leader[Become one, too!] Octapharma Plasma offers professional opportunit...
  • 18 Days Ago

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Oncology Research Specialist – Regulatory Affairs & Compliance – Credentialing/Delegation - Charlotte - FT
  • Candidate Experience site
  • Charlotte, NC FULL_TIME
  • Job Summary Coordinates clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations in...
  • 20 Days Ago

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0 Top Regulatory Affairs Executive jobs found in Concord, NC area

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Sr. QA Manager-Night Shift
  • Eli Lilly and Company
  • Concord, NC
  • At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare lea...
  • 3/29/2024 12:00:00 AM

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CLEANER
  • ABM Industries, Inc.
  • Concord, NC
  • Job Description Position Summary Details The Cleaner position provides the cleaning and upkeep including recycling of an...
  • 3/29/2024 12:00:00 AM

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HR Business Partner
  • ZEISS
  • Concord, NC
  • About Us: How many companies can say they've been in business for over 177 years?! Here at ZEISS, we certainly can! As t...
  • 3/28/2024 12:00:00 AM

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LIMS Project Manager LIMS Project Manager
  • Net2Source
  • Concord, NC
  • ***Job ALERT*** HOT JOB| ***Job ALERT**PRIORITY JOB|***Job ALERT***HOT JOB*** We are #hiring for an Urgent HOT Job in Co...
  • 3/28/2024 12:00:00 AM

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Associate Branch Manager (Forward Hire) - Concord, NC
  • WELLS FARGO BANK
  • Concord, 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...
  • 3/28/2024 12:00:00 AM

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Estimator - Industrial Services
  • Tri-Starr Talent
  • Concord, NC
  • Job Description Job Description Our team is growing! As an Estimator for our Industrial Services Division, you will coll...
  • 3/28/2024 12:00:00 AM

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Warehouse Technician
  • Eli Lilly and Company
  • Concord, NC
  • At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare lea...
  • 3/26/2024 12:00:00 AM

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LIMS Project Manager - On Site - BB2227
  • TechData Service Company LLC
  • Concord, NC
  • Job Description Job Description LIMS Project Manager – On Site - BB2227 BB2227 18+ Months Concord, NC Responsibilities/D...
  • 3/26/2024 12:00:00 AM

Concord (/ˈkɒn.kord/) is a city in Cabarrus County, in the U.S. state of North Carolina. As of the 2010 census, the city had a population of 79,066, with an estimated population in 2018 of 94,546. It is the county seat and the largest city in Cabarrus County. In terms of population, the city of Concord is the second-largest city in the Charlotte Metropolitan Area and is the tenth largest city in North Carolina. In 2015, Concord was ranked as the city with the 16th fastest growing economy in the United States. The city was a winner of the All-America City Award in 2004. Located near the center ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$280,096 to $458,254
Concord, North Carolina area prices
were up 1.5% from a year ago

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