Regulatory Affairs Director jobs in Louisville, KY

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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Senior Director, Quality Assurance & Regulatory Affairs
  • McKesson Corporation
  • Louisville, KY FULL_TIME
  • The state of healthcare is complex, but our shared purpose isn't: Help people get the medicine they need to live healthier lives. CoverMyMeds solves medication access challenges for patients throughout every step of their journey through a unified brand that now encompasses RelayHealth, McKesson Third Party Logistics, McKesson Prescription Automation and CoverMyMeds.

    Job Summary

    Our mission at McKesson Third Party Logistics is to help biopharma, traditional pharmaceutical, and medical device companies accelerate access to the supply chain and reduce risk.

    It is the responsibility of all team members to read, understand, and comply with all policies and procedures that apply to each specific role. It is the obligation of management, managers, supervisors and team leads to ensure quality assurance and compliance with pertinent regulations, policies, and procedures. Management, managers, supervisors and team leads "own" the responsibility of quality assurance and compliance.

    The Senior Director, Quality Assurance and Regulatory Affairs (QARA) collaborates to set policy and procedures and then audits/monitors quality assurance. The Senior Director, QARA is principally responsible for the development and implementation of the Company's quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters. Additionally, the Senior Director, QARA will work closely with and collaborate with the other senior leaders within the Company to provide overall vision, strategy and support of quality assurance initiatives. The focus is on proactive management of quality assurance risks and preventive management as opposed to crisis management. The ideal candidate is a well-spoken, organized, energetic, enthusiastic, and optimistic leader with the ability to work collaboratively with team members, other areas of the McKesson businesses, teams, and clients.

    The Senior Director, Quality Assurance and Regulatory Affairs will have direct access to:

    • All business units within the Company
    • Legal counsel
    • Corporate Quality Assurance, Regulatory, and Compliance teams

    Job Responsibilities:

    • Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team
    • Developing and Implementing written policies, procedures, and standards of conduct for the overall Quality Assurance program to meet all applicable regulatory requirements (21 CFR Parts 11, 210, 211, 820) for Repackager/Relabelers as well as ISO 9001 and state Board of Pharmacy requirements for 3PL activity.
    • Developing effective lines of communication to external and internal customers as well within the organization itself.
    • Conducting periodic risk assessments, internal audits, and developing response plans where appropriate.
    • Provide Governance on various QARA system elements, utilizing data driven approaches and state of control measurements to identify potential trends and take action accordingly.
    • Serve as a key leader in the McKesson 3PL Organization, helping drive positive Quality Culture Values and engaging with leaders of existing and potential clients.
    • Responding promptly on detected offenses, developing corrective action, and reporting findings to the VP, Quality and Regulatory Affairs.

    The Senior Director, QARA and his or her designees have the authority to review all documents and other information that are relevant to quality assurance and regulatory affairs activities. This enables the Senior Director, QARA the ability to review contracts and obligations (seeking the advice of legal counsel, where appropriate) that allow the Company to comply with all contracted obligations.

    In addition, the Senior Director, QARA will be responsible for all internal audit reports and will work closely with key managers to identify trends inconsistent with policies, procedures and contractual obligations. The Senior Director, QARA should ascertain patterns that require a change in policy and forward these issues to the quality assurance committee to remedy the problem.

    Typical Minimum Experience

    • 13 years of relevant Quality Assurance and Regulatory Affairs experience
    • 5 years of management experience
    • 4-year degree in business or related field or equivalent experience
    • Advanced degree a plus (MBA, MS)
    • Must be able to travel up to 30-40%

    Critical Skills

    • 5 years' experience working within Quality Assurance in a government regulated environment
    • Accreditation experience with ISO Standards or regulatory agencies (DEA, FDA, etc.)
    • Must be able to work independently and to be able to make tough and difficult reports when necessary
    • Must be detail-oriented, well-organized self-starter with high energy and creativity and ability to adapt to change in a positive manner
    • Ability to effectively utilize reference materials
    • Excellent oral and written communication skills
    • Strategic problem solving and decision-making ability
    • Ability to effectively manage conflict
    • Computer proficiency in MS Office Suite including intermediate Excel
    • Lean Six Sigma highly preferred

    Physical Requirements

    • Environment (Office, warehouse, etc.) - remote (home) office
    • Travel - requires up to 30-40% travel as needed
    • General office demands (standing/sitting)

    At CoverMyMeds, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at CoverMyMeds, please

    As part of Total Rewards, we are proud to offer a competitive compensation package at CoverMyMeds. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

    Our Base Pay Range for this position

    $142,200 - $237,000

    CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees.Qualified applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability or veteran status.


    McKesson is an equal opportunity and affirmative action employer - minorities/females/veterans/persons with disabilities.

     

  • 26 Days Ago

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Vice Chancellor Academic Affairs
  • Ivy Tech Community College of Indiana
  • Sellersburg, IN FULL_TIME
  • The Vice Chancellor for Academic Affairs is the chief academic officer for the campus and is responsible directly to the Campus Chancellor with indirect reporting to the Sr. Vice President for Academi...
  • 1 Month Ago

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PUBLIC AFFAIRS SPECIALIST (SOCIAL MEDIA)
  • US ARMY HUMAN RESOURCES COMMAND (DRU)
  • Fort Knox, KY FULL_TIME
  • Civilian employees serve a vital role in supporting the Army mission. They provide the skills that are not readily available in the military, but crucial to support military operations. The Army integ...
  • 11 Days Ago

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Senior Staff Environmental Regulatory Compliance Engineer
  • Terracon Consultants, Inc.
  • Louisville, KY FULL_TIME
  • Job Description Are you looking for an Environmental Compliance Leadership Position? Do you thrive on challenges and want a position with advancement potential?Then join our team as an Environmental R...
  • 1 Day Ago

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Youth Challenge Cadre I -Department of Military Affairs
  • Commonwealth of Kentucky
  • Fort Knox, KY FULL_TIME
  • Advertisement Closes 10/1/2023 (8:00 PM EDT) 23-08360 Youth Challenge Cadre I -Department of Military Affairs Pay Grade 12 Salary $39,686.40 Yearly Employment Type EXECUTIVE BRANCH | FULL TIME | ELIGI...
  • 4 Days Ago

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Youth Challenge Cadre Supervisor -Department of Military Affairs
  • kypersonnelcabinet
  • Fort Knox, KY FULL_TIME
  • Youth Challenge Cadre Supervisor -DMA31014818
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in Louisville, KY area

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President/CEO
  • Family Children's Place
  • Louisville, KY
  • ABOUT FAMILY & CHILDREN'S PLACE Family & Children's Place provides resources, support?and solutions to help families pre...
  • 4/26/2024 12:00:00 AM

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Technical Supervisor
  • HealthTrackRx
  • Louisville, KY
  • JOB DESCRIPTION Technical Supervisor- Infectious Disease Department: Analytical Operations – Infectious Disease Manages ...
  • 4/24/2024 12:00:00 AM

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President/CEO
  • Ashley Rountree
  • Louisville, KY
  • ABOUT FAMILY & CHILDREN'S PLACE Family & Children's Place provides resources, support and solutions to help families pre...
  • 4/24/2024 12:00:00 AM

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Project Safety Manager - Louisville
  • Turner Construction Co
  • Louisville, KY
  • **Project Location(s):** Louisville, KY 40206 USA **Minimum Years Experience:** **Education:****Compensation:**Salaried ...
  • 4/24/2024 12:00:00 AM

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Director of Operations, Pharmacy
  • PharmaCord
  • Louisville, KY
  • PharmaCord is seeking a Director of Operations and Workforce Management in our Pharmacy who will play a crucial role in ...
  • 4/23/2024 12:00:00 AM

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President/CEO
  • Family & Children's Place
  • Louisville, KY
  • ABOUT FAMILY & CHILDREN'S PLACE Family & Children's Place provides resources, support and solutions to help families pre...
  • 4/23/2024 12:00:00 AM

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Director of Operations, Pharmacy
  • Pharmacord
  • Louisville, KY
  • PharmaCord is seeking a Director of Operations and Workforce Management in our Pharmacy who will play a crucial role in ...
  • 4/23/2024 12:00:00 AM

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EHS Partner
  • PQ LLC
  • Clarksville, IN
  • Position Title: EHS Partner Type: Full Time Location: Jeffersonville Scope of work: Jeffersonville, Surrey, and Whitecou...
  • 4/22/2024 12:00:00 AM

Louisville and Jefferson County have a combined area of 397.68 square miles (1,030.0 km2), of which 380.46 square miles (985.4 km2) is land and 17.23 square miles (44.6 km2) (4.33%) is covered by water. Louisville is southeasterly situated along the border between Kentucky and Indiana, the Ohio River, in north-central Kentucky at the Falls of the Ohio. Although situated in a Southern state, Louisville is influenced by both Southern and Midwestern culture. It is sometimes referred to as either one of the northernmost Southern cities or as one of the southernmost Northern cities in the United St...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$161,589 to $230,140
Louisville, Kentucky 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