Regulatory Affairs Director jobs in Michigan

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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Director of Pharmaceutical Operations
  • Regulatory Affairs Associates
  • Southfield, MI FULL_TIME
  • **Job Summary:**

    We are seeking a dynamic and experienced Director of Pharmaceutical Operations to oversee our drug company's daily operations and drive business growth. The ideal candidate will possess strong leadership skills, strategic thinking, and a proven track record in FDA regulated operations management.

    **Duties:**

    - Lead and manage the overall operations of drug and cosmetic manufacturing , ensuring efficiency and effectiveness in all processes.

    - Develop and implement strategies to optimize operational performance, achieve business objectives and maintain FDA compliance .

    - Collaborate with senior leadership to set strategic goals and drive business development initiatives.

    - Oversee day-to-day activities, including process improvement, resource allocation, and performance monitoring.

    - Negotiate contracts with vendors, suppliers, and partners to ensure cost-effective operations.

    - Drive continuous improvement through strategic planning, project management, and operational excellence.

    **Qualifications:**

    - Minimum 10 years supervisory management experience in an FDA regulated manufacturing company.

    -Bachelor's degree in Business Administration, Engineering or related field;

    - Proven experience in senior leadership roles with a focus on operations management.

    - Strong background in process improvement, strategic planning, and project management.

    - Excellent negotiation skills with the ability to build strong partnerships.

    - Demonstrated ability to lead cross-functional teams and drive operational excellence.

    This is an outstanding opportunity for a results-driven professional with a passion for operational excellence. If you are ready to take on a challenging yet rewarding role as a Pharmaceutical Director of Operations, we invite you to apply and be part of our dynamic team.

    Job Type: Full-time

    Pay: $96,097.00 - $107,195.00 per year

    Benefits:

    • 401(k)
    • Dental insurance
    • Health insurance
    • Life insurance
    • Paid time off
    • Professional development assistance
    • Relocation assistance
    • Tuition reimbursement
    • Vision insurance

    Experience:

    • FDA regulated manufacturing: 10 years (Required)

    Ability to Commute:

    • Southfield, MI 48034 (Required)

    Ability to Relocate:

    • Southfield, MI 48034: Relocate with an employer provided relocation package (Required)

    Work Location: In person

  • 4 Days Ago

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Director, Regulatory Affairs
  • Volkswagen Group of America - Chattanooga...
  • Auburn, MI FULL_TIME
  • Director, Regulatory Affairs - EEO000221 - Hybrid Primary Location United States-Michigan-Auburn Hills Role Summary: This role serves as the lead regulatory and technical policy coordinator for emissi...
  • 2 Days Ago

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Regulatory Affairs Engineer
  • Talent Acquisition Team
  • Caledonia, MI FULL_TIME
  • ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports the review of updated technical publications and standards to ensure continued compliance Supports the Customer Complaint process and performs MDR and v...
  • Just Posted

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Regulatory Affairs Specialist
  • Chromatech Inc. & B.V.
  • Canton, MI FULL_TIME
  • At Chromatech, we create color solutions in a wide variety of markets around the globe. You can become part of our Chromatech team by joining as a Regulatory Affairs Specialist. The right candidate wi...
  • Just Posted

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Sr Regulatory Affairs Associate
  • Acrisure, LLC
  • GRAND RAPIDS, MI FULL_TIME
  • Acrisure is a global Fintech leader that combines the best of humans and high tech to offer multiple financial products and services to millions of businesses and individual clients. We connect client...
  • 3 Days Ago

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Regulatory Affairs Specialist
  • 1493 SIA MSD Latvija
  • Riga, MI FULL_TIME
  • Job Description Do you want to help our Company become a highly relevant company in Latvia – while opening the doors to exciting, international career opportunities for yourself? Do you dream of a job...
  • 4 Days Ago

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/2/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/2/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/2/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/1/2024 12:00:00 AM

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Regulatory Affairs Director
  • Foundation Medicine
  • Boston, MA
  • About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehens...
  • 5/31/2024 12:00:00 AM

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Regulatory Affairs Director
  • Hiring Now!
  • Boston, MA
  • About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehens...
  • 5/30/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Hiring Now!
  • Horsham, PA
  • Regulatory Affairs Specialistreq38824Employment Type: RegularLocation: HORSHAM,PAHave you ever enjoyed Arnold, Brownberr...
  • 5/29/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 5/29/2024 12:00:00 AM

Michigan consists of two peninsulas that lie between 82°30' to about 90°30' west longitude, and are separated by the Straits of Mackinac. The 45th parallel north runs through the state—marked by highway signs and the Polar-Equator Trail—along a line including Mission Point Light near Traverse City, the towns of Gaylord and Alpena in the Lower Peninsula and Menominee in the Upper Peninsula. With the exception of two small areas that are drained by the Mississippi River by way of the Wisconsin River in the Upper Peninsula and by way of the Kankakee-Illinois River in the Lower Peninsula, Michigan...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$167,257 to $238,213

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019