Regulatory Affairs Director jobs in El Paso, TX

Regulatory Affairs Director oversees regulatory matters and executes the 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 Regulatory Affairs Director 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, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • El Paso, 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.

  • 10 Days Ago

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Business Coordinator (Student Affairs/Alberta)
  • Texas Tech Unv Hlth Sci Ctr El Paso
  • El Paso, TX FULL_TIME
  • Share Business Coordinator (Student Affairs/Alberta) Position Description Performs coordinative work in the business or administrative operation of a specific department or college. Responsibilities i...
  • 3 Days Ago

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Project Director
  • Balfour Beatty Investments & Communities
  • El Paso, TX FULL_TIME
  • Who we are At Balfour Beatty Communities, we are dedicated to a singular mission: delivering the quality communities people are proud to call home. We believe exceptional living experiences can only b...
  • 18 Days Ago

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Director of Telemedicine
  • Clinical Management Consultants
  • El Paso, TX FULL_TIME
  • An exceptional opportunity awaits in the Western Texas region for the role of Director of Telemedicine Services in a hospital setting! This full-time on-site position at a prominent acute care hospita...
  • 20 Days Ago

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STORE DIRECTOR
  • United Supermarkets
  • Pecos, TX FULL_TIME
  • Summary: The Store Director is first and foremost responsible for guest relations and satisfaction by building a reputation for Ultimate Service. He/She is responsible for supervising the efficient, e...
  • 21 Days Ago

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Quality Director
  • Clinical Management Consultants
  • Fort Bliss, TX FULL_TIME
  • An amazing hospital in Southern New Mexico is in search of a new Nurse Director of Quality. This community hospital has made a huge positive impact on the population it serves. It is known for its hig...
  • 21 Days Ago

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0 Regulatory Affairs Director jobs found in El Paso, TX area

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VP of Outpatient Services, FT Days
  • El Paso Children's Hospital
  • El Paso, TX
  • Job Description Under the direction of the Executive Team, the Vice President of Outpatient Services has primary oversig...
  • 3/28/2024 12:00:00 AM

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RN Director of Surgical Services- Registered Nurse DIRECTOR Surgical- MUST HAVE MANAGER EXP- BSN REQ
  • I4 Search Group
  • El Paso, TX
  • Job DescriptionJob Description POSITION TYPE: Registered Nurse (RN) SPECIALTY UNIT: Director of Surgical Services LOCATI...
  • 3/28/2024 12:00:00 AM

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Automation Manager
  • Knowhirematch
  • El Paso, TX
  • Automation Manager Location: Texas We're seeking a visionary and strategic Director of Automation to lead our automation...
  • 3/28/2024 12:00:00 AM

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RN Employee Health and Safety Manager
  • Elpasosurgerycenters
  • El Paso, TX
  • **RN Employee Health and Safety Manager** *star_rate* New **Description** **Introduction** Last year alone, HCA Healthca...
  • 3/28/2024 12:00:00 AM

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Site Administrator
  • Desert Imaging Services
  • El Paso, TX
  • Summary: Responsible for overseeing center operations; provides necessary manpower, supplies, and tools; ensures operati...
  • 3/27/2024 12:00:00 AM

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Admin. Director, Perioperative Services
  • University Medical Center of El Paso
  • El Paso, TX
  • Job Summary Administers, directs, plans, coordinates, monitors, promotes and evaluates all components of Perioperative S...
  • 3/27/2024 12:00:00 AM

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Sales Director - Intelligent Grid Systems - Southeast 2 - Birmingham, AL (Remote)
  • Careerbuilder
  • El Paso, TX
  • Sales Director - Intelligent Grid Systems - Southeast 2 - Birmingham, AL (Remote) Intelligent Grid Solutions is the mark...
  • 3/25/2024 12:00:00 AM

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Dir. Mammography Operations
  • University Medical Center of El Paso
  • El Paso, TX
  • Job Summary Under general direction, plans, organizes, directs the operation of Mammography Operations. Recommends, deve...
  • 3/24/2024 12:00:00 AM

El Paso is located at the intersection of three states (Texas, New Mexico, and Chihuahua) and two countries (the U.S. and Mexico). It is the only major Texas city on Mountain Time. Ciudad Juarez used to be on Central Time, but both cities are now on Mountain Time. El Paso is closer to the capital cities of four other states - Phoenix, Arizona (345 miles away); Santa Fe, New Mexico, (273 miles away); Ciudad Chihuahua, Chihuahua, (218 miles away), and Hermosillo, Sonora (325 miles away) - than it is to the capital of its own state, Austin (528 miles away). It is closer to Los Angeles, California...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$147,416 to $209,953
El Paso, Texas area prices
were up 1.2% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020