Regulatory Affairs Specialist jobs in Brownsville, TX

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
  • Brownsville, 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

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Facilities Specialist
  • SpaceX
  • Brownsville, TX FULL_TIME
  • SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologi...
  • 21 Days Ago

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OFFICE SPECIALIST
  • Cameron County
  • Brownsville, TX FULL_TIME
  • OFFICE SPECIALIST PAY PLAN: 112 - $ 34,175.00 minimum salary JOB ADDRESS: CAMERON COUNTY: Purpose of Classification Performs complex work in clerical support of assigned department. Duties include rec...
  • 23 Days Ago

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Compliance Specialist
  • Upbring
  • Brownsville, TX FULL_TIME
  • Overview About Upbring At Upbring, we are servants on a mission to break the cycle of child abuse. We are warriors, brave as the thousands of Texas Children and families we serve. We stand up for thos...
  • 23 Days Ago

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Parts specialist
  • O'Reilly Auto Parts
  • Brownsville, TX FULL_TIME
  • The Parts Specialist will provide all retail and installer customers with a high level of service. This position will also support store management in the accomplishment of assigned tasks. ESSENTIAL J...
  • 24 Days Ago

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Maintenance specialist
  • Southwest Key Programs
  • Brownsville, TX FULL_TIME
  • Job Summary : The Facilities Maintenance Specialist is responsible for maintaining the facility in a functional, presentable, and safe condition. Essential Functions : Maintain program facility in a s...
  • Just Posted

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0 Regulatory Affairs Specialist jobs found in Brownsville, TX area

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Remote Sales Representative - Work From Home
  • Symmetry Financial Group
  • Brownsville, TX
  • Job Description Overview: We are seeking a highly motivated and results-driven Life Insurance Sales Representative to jo...
  • 3/28/2024 12:00:00 AM

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Biomedical Equipment Support Specialist - OCA
  • U.S. Food and Drug Administration
  • Harlingen, TX
  • ** Biomedical Equipment Support Specialist - OCA** **Department of Veterans Affairs** ** Texas Valley Costal Bend VA Hea...
  • 3/28/2024 12:00:00 AM

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Logistics Manager (RGV)
  • GOODWILL INDUSTRIES OF SOUTH TEXAS INC.
  • Harlingen, TX
  • Description SUMMARY OF POSITION: The Manager of Logistics is responsible for the entire life cycle for agency merchandis...
  • 3/28/2024 12:00:00 AM

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HIM Manager/Coder FT
  • Ernest Health
  • Weslaco, TX
  • Overview: At Weslaco Regional Rehabilitation Hospital, we are passionate about patient care! Nationally Recognized: Our ...
  • 3/28/2024 12:00:00 AM

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Housekeeper - PRN- Days
  • Dhr Rgv
  • Brownsville, TX
  • **Description** *Position at DHR Health* **POSITION SUMMARY****:** To provide routine manual services to assure clean, o...
  • 3/24/2024 12:00:00 AM

Brownsville is one of the southernmost cities in the contiguous United States; only a handful of municipalities in Florida's Miami-Dade and Monroe counties (plus Everglades City in Collier County) are located farther south than Brownsville. The city has a total area of 84.867 square miles (219.805 km2), of which 81.528 square miles (211.157 km2) of it is land and 3.339 square miles (8.648 km2) is water, according to the United States Census Bureau of 2017. The city is situated at the intersection of different climates (subtropical, Chihuahuan Desert, Gulf Coast plain, and Great Plains); this p...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$66,244 to $88,777
Brownsville, Texas 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.
February 20, 2020
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