Top Regulatory Affairs Executive jobs in Pennsylvania

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall 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 Top Regulatory Affairs Executive 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)

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Vice President of Biologics and ATMP Regulatory Affairs
  • Get It Recruit - Executive
  • York Haven, PA FULL_TIME
  • Join our groundbreaking team at Takeda in Boston, MA! We are dedicated to revolutionizing the research and development landscape, with a focus on advancing therapies that make a real difference in the lives of patients globally.

    Role Overview

    As the Vice President of Biologics and ATMP within Global Regulatory Affairs (GRA) at Takeda, you will lead a dynamic team responsible for managing two key therapy modalities. Your pivotal role involves overseeing the entire biologics and ATMP portfolio, including cutting-edge cell and gene therapy products. You will collaborate with various departments to drive innovative strategies for regulatory compliance and product development.

    Responsibilities

    • Lead and ensure the success of biologics and ATMP portfolios.
    • Develop strategies in collaboration with cross-functional teams.
    • Establish robust processes for regulatory compliance.
    • Work closely with quality and commercial teams to enhance products.
    • Represent CMC and GRA on governance committees for technology adoption.
    • Mentor team members and foster their professional growth.

    Key Qualifications

    • Advanced Degree or PhD in Life Sciences, Pharmacy, or a related field.
    • Proficiency in English, additional languages are a plus.
    • Minimum 20 years of experience in regulatory agencies or the Pharmaceutical Industry.
    • Strong leadership skills and ability to manage teams effectively.
    • Excellent communication and collaboration abilities.
    • In-depth knowledge of biologics and ATMP.
    • Familiarity with international regulatory policies.
    • Active engagement in industry associations and regulatory initiatives.

    Compensation And Benefits

    Takeda offers competitive compensation ranging from $252,000.00 to $396,000.00 in Boston, MA, along with a comprehensive benefits package including medical, dental, vision insurance, 401(k) plan, tuition reimbursement, and paid time off.

    Join Us

    Takeda is committed to building a diverse workforce and providing equal employment opportunities to all. Embrace this opportunity to join us in Boston, MA, and be part of an organization driving innovation in healthcare.

    Employment Type: Full-Time
  • 12 Days Ago

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Sales Executive
  • Top Closers
  • Warrington, PA FULL_TIME
  • Are you looking for your next exciting career move in sales? Are you driven, self-motivated, and an excellent communicator? If the answer is YES, then look no further as this is the role for you! We h...
  • 21 Days Ago

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Sales Account Executive
  • Top Talent
  • Indiana, PA FULL_TIME
  • About this role: Inovated company committed to delivering exceptional service to earn trust and further relationships. Integrity, Training and Education Development, Focused on people and accountabili...
  • 1 Day Ago

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Field Sales Executive
  • Top Closers
  • Warrington, PA FULL_TIME
  • Are you looking for your next exciting career move in sales? Are you driven, self-motivated, and an excellent communicator? If the answer is YES, then look no further as this is the role for you! We h...
  • 21 Days Ago

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Regulatory Affairs Technician
  • BioSpectra, Inc.
  • Bangor, PA FULL_TIME
  • At BioSpectra Inc., we pride ourselves on how we effectively deliver high-purity ingredients for the top 25 pharmaceutical companies in the world! We’re proud to set the standard of excellence in our ...
  • 2 Days Ago

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Director of Regulatory Affairs
  • Extremity Care
  • Conshohocken, PA FULL_TIME
  • Purpose: The Director of Regulatory Affairs is responsible for overseeing all regulatory matters, to include the regulatory framework, submissions, and functions to ensure that the quality management ...
  • 3 Days Ago

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Regulatory Affairs Specialist
  • Alphatec Spine
  • Carlsbad, CA
  • Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Experis
  • Maplewood, MN
  • Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Astrix
  • Fort Worth, TX
  • Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • CM Medical Recruitment
  • CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
  • 6/8/2024 12:00:00 AM

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Sr. Specialist, Regulatory Affairs
  • Alphatec Spine
  • Carlsbad, CA
  • The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and interna...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Net2Source Inc.
  • Palo Alto, CA
  • Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
  • 6/7/2024 12:00:00 AM

Pennsylvania (/ˌpɛnsɪlˈveɪniə/ (listen) PEN-sil-VAY-nee-ə), officially the Commonwealth of Pennsylvania, is a state located in the northeastern and Mid-Atlantic regions of the United States. The Appalachian Mountains run through its middle. The Commonwealth is bordered by Delaware to the southeast, Maryland to the south, West Virginia to the southwest, Ohio to the west, Lake Erie and the Canadian province of Ontario to the northwest, New York to the north, and New Jersey to the east. Pennsylvania is the 33rd-largest state by area, and the 6th-most populous state according to the most recent of...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$293,817 to $480,681

Top Regulatory Affairs Executive in Wilmington, NC
On average, a Doctorate Degree is the highest level of education for a Top Regulatory Affairs Executive.
February 04, 2020
Top Regulatory Affairs Executive in Champaign, IL
If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
February 06, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020