Top Regulatory Affairs Executive jobs in Mckinney, TX

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)

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Plano, TX 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

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Rockwall, TX 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

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Frisco, TX 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

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Garland, TX 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

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Dallas, TX 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

I
Regulatory Affairs Associate Analyst
  • Impact Solutions Inc
  • Frisco, TX FULL_TIME
  • Regulatory Affairs Associate Analyst similar job titles: Food Labeling Analyst, Regulatory Affairs Analyst, R&D Regulatory Analyst, R&D Regulatory Coordinator Location: Frisco, TX; 15~ miles north of ...
  • 22 Days Ago

Filters

Clear All

Filter Jobs By Location
  • Filter Jobs by companies
  • More

0 Top Regulatory Affairs Executive jobs found in Mckinney, TX area

J
Chiller Product Engineer
  • Johnson Controls International
  • Apodaca, Nuevo León
  • What you will do: This position is a key part of global air-cooled chiller engineering team. The primary function of thi...
  • 3/29/2024 12:00:00 AM

J
Procurement buyer
  • Johnson Controls International
  • Apodaca, Nuevo León
  • What you will do? You will lead the process for the procurement of 3rd party direct materials for JCI’s Chillers busines...
  • 3/29/2024 12:00:00 AM

J
Chiller Product Engineer
  • Johnson Controls International
  • Apodaca, Nuevo León
  • What you will do: This position is a key part of global air-cooled chiller engineering team. The primary function of thi...
  • 3/29/2024 12:00:00 AM

J
Warranty Specialist II
  • Johnson Controls International
  • Apodaca, Nuevo León
  • Warranty Analyst II What you will do? The position requires a self-motivated associate that can multitask, solve busines...
  • 3/29/2024 12:00:00 AM

J
Harnesses Lean Manufacturing Engineer
  • Johnson Controls International
  • Apodaca, Nuevo León
  • MANUFACTURING ENGINEER – Harness This position is to be fulfilled by a focused and self-motivated engineer to work in a ...
  • 3/29/2024 12:00:00 AM

J
Sheet Metal Lean Manufacturing Engineer
  • Johnson Controls International
  • Apodaca, Nuevo León
  • MANUFACTURING ENGINEER – Sheet Metal Lean Manufacturing Engineer This position is to be fulfilled by a focused and self-...
  • 3/29/2024 12:00:00 AM

L
Material/Property Controller - TS/SCI with Poly
  • Leidos
  • Alice Springs, NT
  • Description The National Security Sector at Leidos currently has an opening for a Material/Property Controller to suppor...
  • 3/28/2024 12:00:00 AM

G
GENERATOR/HVAC Field Service Representative (TESA) in Vicenza, Italy. Must have a current and active Secret clearance.
  • General Dynamics Information Technology
  • GENERATOR/HVAC Field Service Representative ( TESA) in Vicenza Italy. Must have a current and active Secret clearance. A...
  • 3/28/2024 12:00:00 AM

McKinney is a city in and the county seat of Collin County, Texas, United States. It is Collin County's second-largest city, after Plano. Part of the Dallas-Fort Worth metroplex, McKinney is about 32 miles (51 km) north of Dallas. The Census Bureau listed McKinney as the nation's fastest-growing city from 2000 to 2003 and again in 2006, among cities with more than 50,000 people. In 2007, it was ranked second-fastest-growing among cities with more than 100,000 people and in 2008 as third-fastest. In the 2010 census, the city's population was 131,117, making it Texas's 19th-most populous city. T...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$289,317 to $473,338
Mckinney, Texas area prices
were up 2.2% from a year ago

Top Regulatory Affairs Executive in Santa Ana, CA
Based on our compensation data, the estimated salary potential for Top Regulatory Affairs Executive will increase 16 % over 5 years.
February 05, 2020
Top Regulatory Affairs Executive in Wilmington, DE
ERI Economic Research Institute compiles the best salary, cost-of-living, and executive compensation survey data available.
February 01, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020