Regulatory Specialist jobs in the United States

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Associate Director, Promotional Regulatory Affairs
  • 10001223 - Assoc Princ Specialist Regulatory
  • Wilmington, DE FULL_TIME
  • Join us at AstraZeneca, where we turn ideas into life-changing medicines. As an Associate Director in Promotional Regulatory Affairs, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In conjunction with the TA Senior Director, Respiratory & Immunology Therapeutic Area, PRA, you will provide leadership and promotional regulatory expertise to ensure that our promotional practices are consistent with regulatory and legal guidelines.

    Accountabilities:

    As an Associate Director, you will be responsible for reviewing, evaluating, and approving promotional materials and commercial activities within established time frames. You will apply your regulatory and therapeutic area knowledge to meet marketing objectives while minimizing regulatory risk. You will provide regulatory expertise to promotional material review team meetings and business partnering on complex topics. You will also monitor the regulatory environment for your therapeutic area and actively participate in training initiatives of the Promotional Regulatory Affairs Skill Center.

    Essential Skills/Experience:

    • Bachelor’s degree in science

    • 2 years’ experience in regulatory affairs, medical information, clinical development, clinical safety or pharmaceutical advertising agency; or, minimum of 1 year relevant industry experience (e.g., post-doctorate fellowships) plus PharmD/PhD

    • Knowledge of FDA regulations and drug development process

    • Experience in project management and working in a team-based environment

    • Excellent verbal and written communication skills

    • Demonstrated proficiency in the following competencies: exemplary compliance ethics, high concern for standards, significant attention to detail, strategic and analytic thinking

    Desirable Skills/Experience:

    • 3 years’ experience in Promotional Regulatory Affairs

    • Advanced degree in pharmacy, pharmacology, or other life science

    • Direct interaction with various levels of commercial management on issue resolution

    • Experience in Respiratory & Immunology therapeutic area

    • Experience interacting with OPDP, FDA reviewing divisions, or equivalent

    At AstraZeneca, we're not just about treating diseases - we're about changing lives. We're a global biopharmaceutical company that believes in pushing the boundaries of science to deliver life-changing medicines. We're committed to the relentless pursuit of innovation. We believe in the power of what science can do. And we need your talent to help us achieve our mission.

    Are you ready to make a difference? Apply today and help us change the course of medicine!

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

  • 2 Days Ago

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Specialist II, Regulatory Affairs - HYBRID
  • Regulatory Affairs Professionals Society
  • Covington, GA FULL_TIME
  • This job offer is not available in your country. Details Posted : 14-May-24 Location : Covington, Georgia Type : Full Time Categories : Medical Device Quality / Risk Management Submission & Registrati...
  • 5 Days Ago

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • Chicago, IL FULL_TIME|PART_TIME
  • Marketing Operations Manager - OneSource Regulatory Join the OSR Team to transform Marketing/Commercial Operations and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companie...
  • 14 Days Ago

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • REMOTE, FL FULL_TIME|PART_TIME
  • Marketing Operations Manager - OneSource Regulatory Join the OSR Team to transform Marketing/Commercial Operations and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companie...
  • 14 Days Ago

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • Remote, NJ FULL_TIME|PART_TIME
  • Marketing Operations Manager - OneSource Regulatory Join the OSR Team to transform Marketing/Commercial Operations and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companie...
  • 1 Day Ago

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • REMOTE, AZ FULL_TIME|PART_TIME
  • Marketing Operations Manager - OneSource Regulatory Join the OSR Team to transform Marketing/Commercial Operations and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companie...
  • 22 Days Ago

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ACH/Wires Specialist
  • Northwest Federal Credit Union
  • Herndon, VA
  • Overview: The ACH/Wire's Specialist role is to support the internal and external members of the credit union by providin...
  • 5/24/2024 12:00:00 AM

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Regulatory Specialist
  • Technology Ventures
  • Washington, DC
  • The client is seeking a Business Analyst to analyze and prepare documents for translation and to ensure documents on the...
  • 5/23/2024 12:00:00 AM

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Validation/Compliance Engineers- Entry/Mid Level- US Candidates Only!
  • VALIDATION ASSOCIATES LLC
  • Herndon, VA
  • Job Description Job Description MULTIPLE POSITIONS, WITH OUR CLIENTS- NATIONWIDE !!! We are actively looking for fresh t...
  • 5/23/2024 12:00:00 AM

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Regulatory Specialist, Medicaid Contracts
  • Somatus - Revolutionizing Kidney Care
  • Mc Lean, VA
  • OverviewAs the largest and leading value-based kidney care company, Somatus is empowering patients across the country li...
  • 5/23/2024 12:00:00 AM

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FIFRA Regulatory Toxicologist (Ph.D. or M.S.)
  • Exponent Inc.
  • Washington, DC
  • is the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clie...
  • 5/23/2024 12:00:00 AM

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FIFRA Regulatory Toxicologist (Ph.D. or M.S.)
  • Exponent, Inc.
  • Washington, DC
  • About Exponent Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of exp...
  • 5/23/2024 12:00:00 AM

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Senior Data Analyst
  • Technology Company
  • Reston, VA
  • Job Description Job Description Lead Data QA Analyst with Expertise in Data Pipelines, Harvesting, Data Aggregation at S...
  • 5/22/2024 12:00:00 AM

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Field Program Specialist - Raw Milk Handling Procedures
  • Maryland & Virginia Milk Producers Cooperative
  • SUMMARY MUST RESIDE IN THE SOUTH-CENTRAL PENNSYLVANIA OR RELOCATE TO THAT AREA TO BE CONSIDERED We are seeking a Field P...
  • 5/21/2024 12:00:00 AM

Income Estimation for Regulatory Specialist jobs
$64,711 to $82,278