Regulatory Affairs Director jobs in Minnesota

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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Associate Director of Regulatory Affairs
  • Sterling-Hoffman Life Sciences
  • Rochester, MN FULL_TIME
  • Job Description

    Our client, a leading biotechnology company, is currently recruiting an Associate Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:

    • Provide regulatory guidance and strategy for gene therapy programs, including assessing and identifying regulatory risks
    • Manage activities with emphasis on regulatory strategy preparation, review and submission of documents for FDA and other regulatory authorities
    • Review and provide input on all regulatory filing documents
    • Lead and facilitate activities, including team preparation, for meetings with FDA and other regulatory authorities for development activities
    • Be responsible for communicating with FDA and other regulatory authorities
    • Identify issues and develop appropriate regulatory strategies to mitigate risks to filings
    • Ensure stakeholders are informed of developments that may affect regulatory success
    • Perform compliance functions within the company
    • Coordinate and manage regulatory inspections, as needed
    • Stay current with emerging legislation and guidance in the field and contribute to ensuring company-level awareness and compliance

    Critical Requirements

    • A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    • Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    • Recent experience in the biotechnology industry is strongly preferred
    • Preference will be given to candidates with recent experience in regulatory affairs management

    For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.

    Compensation And Other Details

    Base Salary: Highly competitive package, commensurate with experience
  • 2 Days Ago

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Director of Quality Assurance and Regulatory Affairs
  • Interrad Medical
  • Plymouth, MN FULL_TIME
  • The Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Me...
  • Just Posted

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Prof III-Regulatory Affairs-General Regulatory Affairs
  • Baxter
  • Plymouth, MN FULL_TIME
  • Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies...
  • 15 Days Ago

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Regulatory Affairs Specialist III
  • Katalyst HealthCares & Life Sciences
  • Maple, MN CONTRACTOR
  • Responsibilities With adequate supervision, the Regulatory Affairs Specialist III is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as w...
  • Just Posted

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Senior Regulatory Affairs Specialist
  • Laborie
  • Plymouth, MN FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready...
  • Just Posted

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Senior Regulatory Affairs Specialist
  • KYYBA Inc
  • Saint Paul, MN CONTRACTOR
  • Job Description "Exempt/Non Exempt: Non ExemptYears Experience: Must have 3-5 years of experiences in Medical Device Regulatory AffairsSkills:Have working knowledge in EU MDRHave working knowledge in ...
  • Just Posted

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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

Minnesota (/ˌmɪnɪˈsoʊtə/ (listen)) is a state in the Upper Midwest and northern regions of the United States. Minnesota was admitted as the 32nd U.S. state on May 11, 1858, created from the eastern half of the Minnesota Territory. The state has a large number of lakes, and is known by the slogan the "Land of 10,000 Lakes". Its official motto is L'Étoile du Nord (French: Star of the North). Minnesota is the 12th largest in area and the 22nd most populous of the U.S. states; nearly 60% of its residents live in the Minneapolis–Saint Paul metropolitan area (known as the "Twin Cities"). This area i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$173,358 to $246,901

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