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Become A Regulatory Affairs Manager

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Working As A Regulatory Affairs Manager

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Communicating with Supervisors, Peers, or Subordinates
  • Communicating with Persons Outside Organization
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $86,735

    Average Salary

What Does A Regulatory Affairs Manager Do At McKesson

* Conducts customer site visits as necessary for compliance of McKesson’s CSMP.
* This includes travel to pharmacy locations, interacting with customers, conducting interviews, and reviewing pharmacy procedures.
* Performs customer due diligence reviews that include evaluation of system generated reports and analytics; customer dispensing data; review of State licenses and Federal registration; and open source queries that assist in completing comprehensive customer evaluations.
* Completes internal documentation of customer visits, due diligence reviews, and assessments of customers’ regulatory practices and procedures relative to pharmaceutical controlled substances.
* Conducts regulatory reviews and assessments of prospective customers and customer initiated threshold change requests under limited circumstances
* Assists in gathering information relative to manufacturer inquiries and governmental inquiries/subpoena requests.
* Attends industry related conferences and internal training to remain current on regional and national diversion trends, related market trends, and regulatory requirements

What Does A Regulatory Affairs Manager Do At SRA International, Inc., A CSRA Company

* Support interactions with FDA, Europe, Canada and international regulatory authorities.
* Interface with appropriate internal departments such as Manufacturing, Testing & Technical Services; Clinical Research; Nonclinical and Quality Assurance to ensure timely submissions including tracking of communication to and from the FDA, Europe, Canada and international regulatory authorities.
* Assist in the development and implementation of regulatory filing strategies and project coordination during the development of an IND and commercial filing applications.
* Provide technical writing, review, editing, and formatting of drafts and related materials for all sections of regulatory applications.
* Perform critical review of regulatory documents for writing standards, logic, content, presentation, clarity and accuracy of CMC, Clinical, and Nonclinical data.
* Ensure that all CMC/nonclinical/clinical documentation, which directly or indirectly supports the preparation of regulatory submissions, are prepared to meet domestic and international requirements.
* Assist Regulatory Operations in the preparation and assembly of submissions to regulatory agencies

What Does A Regulatory Affairs Manager Do At Pfizer

* Provides guidance to and/or may lead/co-lead moderately complex projects Manages own time to meet objectives for assigned projects Develops regulatory strategies for Legacy Hospira Proprietary projects and analyzes risk vs. benefit to ensure successful review by regulatory authorities.
* Author with team members, key pieces of regulatory submissions.
* Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams.
* Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions and electronic common technical documents (e
* CTD) for registration packages and responses to deficiency letters.
* Management and review of periodic reports and renewals in accordance with scheduled time lines Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
* Evaluates manufacturing and labeling changes for regulatory impact and to ensure compliance with applicable regulations.
* Accurately describes these changes for ease of regulatory agency review.
* Maintains awareness of global regulatory legislation and assesses its impact on business and assigned projects/programs

What Does A Regulatory Affairs Manager Do At Amgen

* Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards
* Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)
* Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
* Write other regulatory submission documents (e.g., RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
* Manage study timelines for regulatory documents and regulatory submission strategy
* Act as a functional area representative and lead on product teams
* Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
* Ensure quality of regulatory submission documents at all stages of development
* Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
* Participate in departmental meetings, as well as departmental and cross-departmental initiatives

What Does A Regulatory Affairs Manager Do At Medtronic

* Develop global regulatory strategies for medical device, pharmaceutical, and combination product to meet business objectives.
* Participate on Product Development teams, providing regulatory strategy, timelines, and direction.
* Review and approve design verification, design validation and stability protocols and reports.
* Organize and prepare high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.
* Negotiate with regulatory authorities to resolve questions/issues that arise during submission review.
* Drive product change assessments and define regulatory impact of product changes in global markets.
* Provide documentation to geographies that require a submission or amendment.
* Review and approve labeling, training, promotional, and advertising material.
* Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements.
* Ensure compliance with Medtronic, U
* S. FDA, and international requirements.
* Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.
* Interprets and executes policies and procedures that typically affect subordinate organizational units.
* Recommends modifications to operating policies.
* Create and maintain regulatory affairs department procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.
* Participate on audit and field action teams.
* Sponsor and actively monitor a performance management culture where employees have clear performance expectations.
* Provide targeted coaching and feedback.
* Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly.
* Conduct timely and candid performance evaluations.
* Support meaningful development activities

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Regulatory Affairs Manager jobs

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Regulatory Affairs Manager Demographics

Gender

  • Female

    52.6%
  • Male

    44.7%
  • Unknown

    2.8%

Ethnicity

  • White

    75.7%
  • Asian

    11.1%
  • Hispanic or Latino

    9.8%
  • Unknown

    2.5%
  • Black or African American

    0.8%
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Languages Spoken

  • Spanish

    29.4%
  • French

    18.8%
  • German

    11.8%
  • Portuguese

    5.9%
  • Chinese

    5.9%
  • Mandarin

    4.7%
  • Italian

    4.7%
  • Russian

    3.5%
  • Czech

    2.4%
  • Hindi

    2.4%
  • Arabic

    2.4%
  • Haida

    1.2%
  • Dutch

    1.2%
  • Vietnamese

    1.2%
  • Japanese

    1.2%
  • Carrier

    1.2%
  • Slovak

    1.2%
  • Gujarati

    1.2%
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Regulatory Affairs Manager

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Regulatory Affairs Manager Education

Regulatory Affairs Manager

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Real Regulatory Affairs Manager Salaries

Job Title Company Location Start Date Salary
Senior Governance and Regulatory Affairs Manager The Royal Bank of Scotland PLC Stamford, CT Sep 01, 2015 $200,000
Regulatory Affairs Manager Stripe, Inc. San Francisco, CA Feb 16, 2016 $175,000
Senior Regulatory Affairs Manager St. Jude Medical Cardiology Division Saint Paul, MN Aug 20, 2016 $169,500
Global Regulatory Affairs, Latin America Manager Bayer Healthcare Pharmaceuticals NJ Nov 25, 2016 $160,078
Regional Regulatory Affairs Manager-Latin America Bayer Healthcare Pharmaceuticals, Inc. NJ Mar 09, 2016 $157,016
Manager, Regulatory Affairs Cutanea Life Sciences Inc. Wayne, PA Oct 01, 2015 $150,000
Regulatory Affairs Manager API Inc. Fairfield, NJ Jun 24, 2015 $149,594
Manager, Regulatory Affairs Non-Sterile TEVA Pharmaceuticals USA, Inc. Horsham, PA Nov 01, 2016 $145,500 -
$150,500
Regulatory Affairs Manager Citron Pharma LLC East Brunswick, NJ Jun 15, 2015 $144,310
Manager, Regulatory Affairs TEVA Pharmaceuticals USA Inc. Horsham, PA Dec 14, 2015 $138,944 -
$145,000
Manager, Regulatory Affairs TEVA Pharmaceuticals USA Horsham, PA May 04, 2015 $138,944 -
$144,000
Manager, CMC Regulatory Submissions Shire Human Genetic Therapies Inc. Lexington, MA May 15, 2016 $138,000
Manager, Global Regulatory Affairs CMC Reckitt Benckiser Pharmaceuticals, Inc. Richmond, VA Jun 26, 2015 $135,824
Regulatory Affairs Manager Allergan Sales, LLC (Subsidiary of Allergan, Inc.) Irvine, CA Aug 28, 2015 $135,000
Senior Publisher, Regulatory Affairs Abbvie Inc. North Chicago, IL May 05, 2016 $117,947
Manager, Regulatory Affairs Development Takeda Development Center Americas, Inc. Deerfield, IL Jul 10, 2016 $116,500 -
$178,200
Manager, Regulatory Affairs, CMC Abbvie Inc. North Chicago, IL Jul 22, 2015 $115,119
Manager, Regulatory Affairs Vertex Pharmaceuticals, Inc. Boston, MA Feb 15, 2016 $115,000 -
$135,000
Manager, Scientific Affairs (Claims) ELC Management LLC Melville, NY Aug 24, 2015 $115,000
Manager, Regulatory Affairs Goodman Manufacturing Company, L.P. Herndon, VA Apr 28, 2016 $115,000
Senior Publisher, Regulatory Affairs Abbvie Inc. North Chicago, IL Aug 10, 2015 $113,750
Regulatory Affairs Manager Generics Bidco II Charlotte, NC Feb 15, 2015 $112,000
Regulatory Affairs Engineer Intuitive Surgical Operations, Inc. Sunnyvale, CA Feb 29, 2016 $97,947 -
$117,947
Regulatory Affairs Engineer Intuitive Surgical Operations, Inc. Sunnyvale, CA Jan 12, 2015 $97,926 -
$122,600
Regulatory Affairs, Senior Manager Amneal Pharmaceuticals, LLC Piscataway, NJ Sep 25, 2016 $96,262
Regulatory Affairs Manager Amgen Inc. Thousand Oaks, CA Oct 21, 2015 $95,000
Regulatory Affairs Manager Neurologica Corporation A Subsidary of Samsung Danvers, MA Jan 26, 2015 $95,000
Regulatory Affairs Manager Medivators, Inc. Plymouth, MN Apr 14, 2016 $95,000
Regulatory Labeling Manager Amgen Inc. Thousand Oaks, CA Oct 15, 2015 $94,438
Regulatory Labeling Manager Amgen Inc. Thousand Oaks, CA Oct 23, 2015 $94,438

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Top Skills for A Regulatory Affairs Manager

FDARegulatoryAffairsProceduresSafetyRegulatoryStandardsINDRegulatoryStrategiesRegulatorySubmissionsRegulatoryAgenciesISOCMCInternalAuditsQualitySystemAnnualReportsEnsureRegulatoryComplianceRegulatoryRequirementsEUProductDevelopmentRegulatoryIssuesGlobalRegulatory

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Top Regulatory Affairs Manager Skills

  1. FDA
  2. Regulatory Affairs
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Write, coordinate, compile, manage and submit Regulatory documents to FDA and other Regulatory Agencies, including International Authorities.
  • Designed a secure, standardized Worldwide Regulatory Affairs eRoom (electronic dossier compilation and storage center).
  • Responded, investigated, and resolved faculty and student issues in conjunction with University policies and procedures.
  • Research and review product formulas for safety analysis.
  • Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidance.

Top Regulatory Affairs Manager Employers

Regulatory Affairs Manager Videos

Designing Your Career as a Regulatory Professional

Integra LifeSciences: Day in the Life of a Rotational Associate - Clinical Affairs

Senior Quality Engineer | Regulatory Affairs Manager [bkjrecruiter]

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