Regulatory Affairs Director jobs in Tulsa, OK

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
  • Tulsa, OK 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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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Broken Arrow, OK 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

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Director - Academic Affairs and Graduate Student Services
  • Oklahoma State University
  • Tulsa, OK FULL_TIME
  • Job Summary Provide direction, leadership, and supervision in Academic Affairs and Graduate Student Services. Oversee the promotion of Tulsa-based graduate programs and assist program coordinators wit...
  • 10 Days Ago

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LPN Floor Nurse
  • Ok Department Of Veterans Affairs
  • Claremore, OK FULL_TIME
  • ODVA is seeking full-time LPN Floor Nurses for a State Veterans Home located in Claremore, OK . ODVA offers a comprehensive Benefits Package, including a generous benefit allowance to offset the cost ...
  • 3 Days Ago

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Juvenile justice specialist
  • Oklahoma Office of Juvenile Affairs
  • McAlester, OK FULL_TIME
  • Compensation JJS IV - $26.53 an hour 'This position is a safety sensitive position as defined by 63 O.S. 427.8 (K)(1)(i)(2) due to providing direct childcare. Therefore, those applicants testing posit...
  • 3 Days Ago

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RN Unit Manager
  • OK Department of Veterans Affairs
  • Claremore, OK FULL_TIME
  • ODVA is seeking full-time RN Unit Managers for a State Veterans Home located in Claremore, OK . ODVA offers a comprehensive Benefits Package, including a generous benefit allowance to offset the cost ...
  • 4 Days Ago

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0 Regulatory Affairs Director jobs found in Tulsa, OK area

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Senior Claims Specialist/Senior Claims Technical Director
  • Mid-Continent Group
  • Tulsa, OK
  • We are adding an experienced Senior Claims Specialist or Senior Claims Technical Director to our diverse claims team. Th...
  • 3/28/2024 12:00:00 AM

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Senior Claims Specialist/Senior Claims Technical Director
  • Great American Insurance Group
  • Tulsa, OK
  • Mid-Continent Group underwrites specialty commercial insurance and contract surety products. Mid-Continent Group special...
  • 3/28/2024 12:00:00 AM

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LPN - Tulsa, OK
  • KARE
  • Tulsa, OK
  • Join the KARE Revolution! Our mission is to transform caregivers and nurses like you into KARE Heroes who can save the d...
  • 3/28/2024 12:00:00 AM

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Residence Hall Director
  • Oral Roberts University
  • Tulsa, OK
  • ABOUT US Oral Roberts University is a non-profit organization whose staff and faculty actually make a difference in the ...
  • 3/28/2024 12:00:00 AM

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Psychiatric Research Program Administrator
  • Laureate Institute for Brain Research
  • Tulsa, OK
  • Position Overview: LIBR seeks a highly organized, detail-oriented, and dynamic program administrator to support our Scie...
  • 3/28/2024 12:00:00 AM

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Sr. Security Analyst
  • System Soft Technologies
  • Tulsa, OK
  • looking for a Security Analyst with a primary focus on installing, configuring, maintaining, and driving the improvement...
  • 3/27/2024 12:00:00 AM

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Adjunct Faculty - Veterinary Technology (Radiology)
  • Tulsa Community College
  • Tulsa, OK
  • Job Summary The ideal candidate has the primary responsibility of instruction in the classroom, clinical sites and labor...
  • 3/27/2024 12:00:00 AM

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Admissions Advisor
  • Atlas School
  • Tulsa, OK
  • Role: Admissions Advisor At Atlas School, we are dedicated to our students’ success and committed to providing them with...
  • 3/26/2024 12:00:00 AM

Tulsa is located in the northeastern corner of Oklahoma, 99 miles (159 km) northeast of Oklahoma City; situated between the edge of the Great Plains and the foot of the Ozarks in a generally forested region of rolling hills. The city touches the eastern extent of the Cross Timbers, an ecoregion of forest and prairie transitioning from the drier plains of the west to the wetter forests of the east. With a wetter climate than points westward, Tulsa serves as a gateway to "Green Country", a popular and official designation for northeast Oklahoma that stems from the region's green vegetation and r...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$160,517 to $228,611
Tulsa, Oklahoma 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