Regulatory Affairs Manager jobs in Jackson, MS

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)

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Jackson, MS 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

C
QIDP- Case Manager
  • Case Manager
  • Brookhaven, MS FULL_TIME,PART_TIME
  • POSITION PURPOSE: Responsible for the day-to-day delivery of individual support program services to assigned case load in accordance with Federal, State, and facility codes, regulations, guidelines an...
  • 9 Days Ago

V
Secretary
  • Veterans Affairs, Veterans Health Administration
  • Jackson, MS FULL_TIME
  • Summary This position directly supports and works under the supervision of the Chief Financial Manager, also referred to as the Service Chief. The position provides secretarial support to the Chief Fi...
  • 1 Month Ago

T
Regulatory Reporting Analyst II/III
  • Trustmark
  • Jackson, MS FULL_TIME
  • Overview The purpose of this role is to support the processes that ensure data integrity and accuracy for required regulatory annual filings for the Home Mortgage Disclosure Act (HMDA) and Small Busin...
  • 2 Days Ago

A
Director, Office of Faculty Affairs/Center for Faculty/Staff Innovation
  • Alcorn State University
  • Lorman, MS FULL_TIME
  • Please see Special Instructions for more details. EEO Statement: Alcorn State University does not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, age, dis...
  • 1 Month Ago

T
Manager
  • The F.R.O.G.
  • Magee, MS FULL_TIME
  • The F.R.O.G. in Magee, MS is looking for a store manager to join our strong team. We are located on 309 Pinola Dr Sw. Our ideal candidate is attentive, motivated, and engaged.Responsibilities Train, c...
  • 20 Days Ago

Filters

Clear All

Filter Jobs By Location
  • Filter Jobs by companies
  • More

0 Regulatory Affairs Manager jobs found in Jackson, MS area

U
Chief - Payer Relations & Managed Care
  • University of Mississippi Medical Center
  • Jackson, MS
  • Hello, Thank you for your interest in career opportunities with the University of Mississippi Medical Center. Please rev...
  • 3/28/2024 12:00:00 AM

B
RN-Nurse Manager - JS Surgery Outpatient MBMC
  • Baptist Memorial
  • Jackson, MS
  • Summary Develops, administers, directs, and implements all nursing and related patient care activities for areas of acco...
  • 3/28/2024 12:00:00 AM

U
Ophthalmic Surgical Tech-Ophthalmology-Lakeland
  • University of Mississippi Medical Center
  • Jackson, MS
  • Hello, Thank you for your interest in career opportunities with the University of Mississippi Medical Center. Please rev...
  • 3/28/2024 12:00:00 AM

U
RN I Ambulatory - Pediatric Cardiology Clinic
  • University of Mississippi Medical Center
  • Jackson, MS
  • Hello, Thank you for your interest in career opportunities with the University of Mississippi Medical Center. Please rev...
  • 3/28/2024 12:00:00 AM

D
Internal Revenue Agent (Examiner) - (Temp NTE 1 Year, MBE, MBMP) 12 MONTH ROSTER (AMENDED)
  • Department Of The Treasury
  • Jackson, MS
  • Duties WHAT IS THE SMALL BUSINESS/SELF EMPLOYED (SB/SE)DIVISION? A description of the business units can be found at: ht...
  • 3/27/2024 12:00:00 AM

D
Clinical Nurse
  • Department of Defense
  • Jackson, MS
  • Summary Click on "Learn more about this agency" button below for IMPORTANT additional information. This position will su...
  • 3/27/2024 12:00:00 AM

H
Commercial Loan Processor
  • Hope Credit Union
  • Jackson, MS
  • Job Summary The Commercial Loan Processor (CLP) will be responsible for receiving and processing all incoming loans for ...
  • 3/26/2024 12:00:00 AM

C
HSE Supervisor - Remote within Baltimore, Maryland
  • CBRE
  • Jackson, MS
  • HSE Supervisor - Remote within Baltimore, Maryland Job ID 152427 Posted 25-Jan-2024 Service line GWS Segment Role type F...
  • 3/24/2024 12:00:00 AM

Jackson is located primarily in northeastern Hinds County, with small portions in Madison and Rankin counties. The Pearl River forms most of the eastern border of the city. A small portion of the city containing Tougaloo College lies in Madison County, bounded on the west by Interstate 220 and on the east by U.S. Route 51 and Interstate 55. An unconnected section of the city surrounds Jackson–Evers International Airport in Rankin County. In the 2010 census, only 622 of the city's residents lived in Madison County, and only 1 lived within the city limits in Rankin County. The city is bordered t...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$122,971 to $173,448
Jackson, Mississippi 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