Regulatory Affairs Manager jobs in Lake Charles, LA

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Charles, LA 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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Start-Up Manager
  • Up Manager - Worley Careers
  • Cameron, LA FULL_TIME
  • Building on our past. Ready for the future Worley is a global professional services company of energy, chemicals and resources experts headquartered in Australia.? Right now, we’re bridging two worlds...
  • 1 Day Ago

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Regulatory Compliance Officer
  • Caesars Entertainment
  • Westlake, LA FULL_TIME
  • ESSENTIAL JOB FUNCTIONS: · Serves as the property’s designated BSA Compliance Officer for regulatory purposes. · Safeguard property assets. · Compile and/or review CTRCs and SARs when necessary. · Des...
  • 21 Days Ago

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Lk Chas Public Affairs Co-op/Intern
  • Citgo Petroleum Corporation
  • Charles, LA INTERN
  • Our Favorite CITGO Perks are:* 9/80 work schedule option * Paid holidays * Company sponsored scholarship opportunities * On-site fitness center * On-site Health Clinic PLEASE NOTE ALL JOBS DO NOT QUAL...
  • 1 Month Ago

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Right of Way Regulatory Permit Agent - Lake Charles, LA
  • Percheron Operating
  • Lake Charles, LA FULL_TIME
  • Job Description: Percheron is looking for an experienced Right of Way Regulatory Permit Specialist to support non-environmental permit efforts out of our field office in Lake Charles, LA. Per diem is ...
  • 2 Days Ago

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Manager
  • R. J. Corman Railroad Group
  • Westlake, LA FULL_TIME
  • Corman Switching Company has an opening for a Track Manager in Westlake, LA to assist in the safe, efficient, and general management of the track maintenance operations at our Westlake, LA switching l...
  • 4 Days Ago

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0 Regulatory Affairs Manager jobs found in Lake Charles, LA area

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Care Manager II, Case Management - Full Time
  • Christus Health
  • Lake Charles, LA
  • Description Summary: The Care Manager (CM) II works in collaboration with the patient/family, physicians and multidiscip...
  • 3/28/2024 12:00:00 AM

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Care Manager II, Case Management - Full Time
  • Christus Health
  • Lake Charles, LA
  • Description Summary: The Care Manager (CM) II works in collaboration with the patient/family, physicians and multidiscip...
  • 3/28/2024 12:00:00 AM

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Lead Environmental Specialist
  • Bridgestone Americas, Inc.
  • Lake Charles, LA
  • Company Overview Firestone Polymers, LLC is headquartered in Lake Charles, LA and manufactures polymers and synthetic ru...
  • 3/28/2024 12:00:00 AM

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Sr. Safety Specialist
  • Indorama Ventures
  • Westlake, LA
  • Job Description: Indorama Integrated Oxides & Derivatives is currently looking for a dynamic individual to work as a Sen...
  • 3/28/2024 12:00:00 AM

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Pharmacist - Sign-On Bonus and Relocation Available
  • WALGREENS
  • Lake Charles, LA
  • Job Objectives Provides pharmacy consulting services with empathy to patients regarding the effective usage of medicatio...
  • 3/27/2024 12:00:00 AM

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Floor Supervisor
  • Caesars Entertainment
  • Westlake, LA
  • Job Description Job Summary: Implement and ensure compliance with approved procedures, train, supervise, and monitor per...
  • 3/27/2024 12:00:00 AM

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LPN Peds Private Duty
  • LHC Group
  • Lake Charles, LA
  • Job Description We are hiring for a Pediatric Private Duty LPN (Licensed Practical Nurse) in the Lake Charles area to pr...
  • 3/25/2024 12:00:00 AM

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Structural Engineer 5- Substation- US Hybrid
  • Black & Veatch
  • Westlake, LA
  • **Structural Engineer 5- Substation- US Hybrid** Date: Mar 22, 2024 Location: US Company: Black & Veatch Family of Compa...
  • 3/25/2024 12:00:00 AM

Lake Charles (French: Lac Charles) is the fifth-largest incorporated city in the U.S. state of Louisiana, located on Lake Charles, Prien Lake, and the Calcasieu River. Founded in 1861 in Calcasieu Parish, it is a major industrial, cultural, and educational center in the southwest region of the state. As of the 2010 census, the population was 71,993. Lake Charles is the principal city of the Lake Charles Metropolitan Statistical Area, having a population of 202,040. It is the larger principal city of the Lake Charles-Jennings Combined Statistical Area, with a population of 225,235. The 2010 pop...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$124,498 to $175,603
Lake Charles, Louisiana area prices
were up 1.2% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020