Regulatory Relations Liaison jobs in Lowell, MA

Regulatory Relations Liaison is responsible for filing necessary applications and handling all government interactions pertaining to the regulation and certification process for a plant or other facility. Develops procedures to ensure regulatory compliance. Being a Regulatory Relations Liaison prepares reports for top management detailing projects that may impact the organization's regulation status. May represent the organization before federal or state legislations. Additionally, Regulatory Relations Liaison requires a bachelor's degree. Typically reports to a manager or head of a unit/department. The Regulatory Relations Liaison 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 Relations Liaison 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 Regulatory Affairs Consultant / Regulatory Project Lead
  • Parexel International Corporation
  • Billerica, MA FULL_TIME
  • If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E-X-P-A-N-D-I-N-G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight knit team of amazingly nice and extremely experienced colleagues!

    As a Senior Regulatory Affairs Consultant / Regulatory Project Lead you will provide leadership to highly experienced project teams and manage the day-to-day operations and complexities of preparing and filing NDA and/or BLA applications. You will strive to achieve operational excellence through on time delivery that is within budget and to the highest quality with the goal to exceed client expectations.

    Qualifications:

    Successful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at least 10-15 years' experience working in a similar capacity leading US FDA filings within a CRO, Biotech, or a Pharmaceutical Company (previous CRO or Consulting firm experience is highly preferred). Past experience overseeing a cross-functional team involved in the creation of US Regulatory Filings to include NDAs and/or BLAs is required. Previous vaccines experience is a plus!

    This position also requires experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience in Regulatory Affairs related activities.

    Successful candidates must also possess the following:

    *The ability to build and sustain relationships
    *Critical thinking and problem solving
    *The ability to influence and lead teams
    *Financial management skills
    *Strategic thinking skills
    *Attention to detail and commitment to quality
    *Conflict management skills
    *Consulting skills
    *Contingency planning and risk management skills
    *People management skills
    *Excellent interpersonal, verbal and written communication skills
    *Client focused approach to work
    *A flexible attitude with respect to work assignments and new learning
    *Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
    *Bilingual candidates who are fluent in oral and written English and Korean are highly preferred
    *Proficient in Microsoft Excel, Power Point, MS Project and Word.
    *Experience with Parexel systems is a plus
    *Willingness to work in a matrix environment and to value the importance of teamwork.
    *Experience with financials and managing project budgets

    Up to approximately 20% Domestic and/or International Travel may be required in the future

    Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.


    #LI-REMOTE

     

  • 19 Days Ago

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Regulatory Affairs Specialist
  • Zoll Medical Corporation
  • Chelmsford, MA FULL_TIME
  • Regulatory Affairs Specialist Location: Chelmsford, MA, United States of America Resuscitation At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative ...
  • 19 Days Ago

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Regulatory Affairs Co-op
  • Zoll Medical Corporation
  • Chelmsford, MA FULL_TIME
  • Regulatory Affairs Co-op Location: Chelmsford, MA, United States of America Resuscitation ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save li...
  • 20 Days Ago

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Regulatory Affairs Program Associate
  • ZOLL LifeVest
  • Chelmsford, MA FULL_TIME
  • Location: Chelmsford, MA Resuscitation At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people...
  • 21 Days Ago

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Regulatory Affairs Program Associate
  • ZOLL Medical
  • Chelmsford, MA FULL_TIME
  • Resuscitation, ZOLLMED.com At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Ou...
  • 25 Days Ago

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Director, Regulatory Affairs
  • Zoll Medical Corporation
  • Chelmsford, MA FULL_TIME
  • Director, Regulatory Affairs Location: Chelmsford, MA, United States of America Resuscitation ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to sav...
  • 1 Day Ago

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0 Regulatory Relations Liaison jobs found in Lowell, MA area

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Outpatient Clinician
  • Beth Israel Lahey Health
  • Lawrence, MA
  • When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. Job Typ...
  • 3/28/2024 12:00:00 AM

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Manufacturing Associate
  • The Steely Group
  • Bedford, MA
  • Job Description Job Description Shift hours will be 12pm-12am for this role (2nd shift) Our client is looking for innova...
  • 3/28/2024 12:00:00 AM

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IT Business Partner of Finance
  • Engtal
  • Andover, MA
  • Position: IT Business Partner/SME for Finance Reports To: Director, Enterprise Business Systems This multifaceted role n...
  • 3/27/2024 12:00:00 AM

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IT Business Partner SME for Finance
  • EDI Staffing
  • Andover, MA
  • Onsite Role - Salary 120-140K This multifaceted role needs a strategic mindset to align IT solutions with the functional...
  • 3/27/2024 12:00:00 AM

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Director of Life Sciences
  • GCR Technical Staffing
  • Billerica, MA
  • Job Description Job Description The Director will be entrusted with the strategic growth of this portfolio, leading a ta...
  • 3/26/2024 12:00:00 AM

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Vice President of Environmental Health and Safety, EHS
  • ICP Group
  • Andover, MA
  • Innovative Chemical Products Group (ICP Group) is a leading formulator and manufacturer of specialty coatings, adhesives...
  • 3/26/2024 12:00:00 AM

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IT Business Partner - Finance
  • TransMedics, Inc.
  • Andover, MA
  • Position: IT Business Partner/SME for Finance Reports To: Director, Enterprise Business Systems This multifaceted role n...
  • 3/25/2024 12:00:00 AM

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Food Service Manager - Patient Services
  • Aramark
  • Tewksbury, MA
  • Job Description Aramark Healthcare+ is searching for a Food Service Manager of Patient Services at Tewksbury Hospital, a...
  • 2/7/2024 12:00:00 AM

Lowell is a city in the U.S. Commonwealth of Massachusetts. Located in Middlesex County, Lowell (along with Cambridge) was a county seat until Massachusetts disbanded county government in 1999. With an estimated population of 109,945 in 2014, it is the fourth-largest city in Massachusetts, and the second-largest in the Boston metropolitan statistical area. The city is also part of a smaller Massachusetts statistical area called Greater Lowell, as well as New England's Merrimack Valley region. Incorporated in 1826 to serve as a mill town, Lowell was named after Francis Cabot Lowell, a local fi...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Liaison jobs
$136,840 to $166,365
Lowell, Massachusetts area prices
were up 1.6% from a year ago