Today, the biggest challenge for our industry is finding qualified talent in Regulatory functions.  Due to high employment rates and the specific needs of the clients, selecting a partner to make timely allocation of right resources has become a critical factor.  In such scenarios, choosing Freyr – a Regulatory contract staffing partner will help you overcome the resource gaps on time. Freyr has a track record of success in having helped companies to successfully meet their organizational needs.

With a top-notch recruiting department backed by over 700+ qualified Regulatory professionals, Freyr assists clients to choose the right person at the right time. Freyr offers Regulatory contract staffing services across the USA, Canada, South America, Europe, UK, Middle East, Africa, Asia, for industries such as Medical Devices, Cosmetics, Consumer Healthcare products, Pharmaceutical (Generics, New Drug), Biologics (Innovators and Biosimilars) etc.  Freyr’s Regulatory contract staffing capabilities span across several Regulatory functionalities; a few sample skill sets are outlined below:

Freyr Regulatory Contract Staffing Expertise
(Representative List of Skill Sets)


Regulatory Affairs

CMC

  • Regulatory CMC Author
  • Regulatory CMC Expert
  • Regulatory CMC Manager
  • Regulatory Strategist
  • Regulatory Senior Strategist
  • CMC Specialist
  • CMC Information Management

Market Authorization Applications

  • Regulatory Project Manager
  • Regulatory Affairs specialist – NDA, IND, CTA, IMPD, ANDA, BLA, PMA/510K, Global MAH
  • Regulatory Lifecycle and Global Dossier Coordinator / Dossier Compilation Project Coordinator
  • Dossier Preparation Specialist


Compliance and Audit

Compliance and Validation

  • Head 
  • Lead
  • Business Process Specialist 
  • Senior Associate
  • Associate
  • GCP / GMP / GxP Auditor
  • QMS Remediation Expert
  • GxP Solution Consultant

Compliance and Audit

  • Assistant manager
  • Business Process Specialist
  • Business Process Analyst
  • Senior Associate

Validation

  • Business Process Specialist
  • Business Process Analyst
  • Senior Associate
  • Associate


Consumer, Cosmetics & Food Supplements

  • Regulatory Specialist
    • Senior Regulatory specialist
    • Junior Regulatory specialist
    • Coordinators
  • Subject Matter Expert/ Solutioning Lead
  • Global Project Manager / Program Manager
  • Label Content and QC Specialist
  • Label Content Expert
  • Regulatory Document Translator
  • Local Support Expert
  • Legal Representative/ License Holding
  • Local Language Expert
  • Responsible Person
  • Content Management Expert
  • Administrative Support Associate
  • Client Call Expert
  • Claims Consulting Expert
  • Regulatory Strategist 


Labeling

  • Global/ Regional Labeling Coordinator
  • Global Labeling Lead
  • Regulatory Strategist
  • Labeling Manager
  • Labeling Expert/Specialist
  • Senior Labeling Specialist
  • Labeling Program Manager
  • Labeling Project Manager
  • Regulatory Labeling Associate
  • Core Data Sheet (CDS) Manager
  • CDS Development Lead
  • Label Content Experts / Medical Writers and Authors - Core Data Sheet (CDS), Summary of Product Characteristics (SmPC), Package Insert (PI), Patient Information Leaflet (PIL), Regional Labels
  • CDS / Regional Label Content and Process Coordinator
  • Global Labeling Project / Program Manager
  • Label Content – Quality Control (QC) Specialist


Regulatory Medical Writing/ Pharmacovigilance (PV)/PDE

Medical Writing Staffing Roles

  • Medical Writer
  • Content Specialist
  • Regulatory Medical Writer
  • Senior Medical Writer
  • Quality Reviewer
  • Medical Reviewer
  • Clinical Expert
  • Clinical Lead
  • Clinical Trial Monitoring Specialist
  • QC Expert
  • QC Specialist
  • Nonclinical Expert
  • Nonclinical Writer
  • Toxicologist

Pharmacovigilance 

  • Safety Associate
  • Safety Expert
  • Pharmacovigilance Expert
  • Pharmacovigilance Scientist
  • Safety Lead
  • Literature Monitor
  • Aggregate Report Writer
  • Aggregate Report Specialist
  • Quality Reviewer
  • Medical Reviewer
  • Signal Evaluation Specialist
  • Signal Evaluation Expert
  • Safety Data Specialist
  • Safety Data Lead

PDE 

  • Nonclinical Expert/Senior Nonclinical Writer
  • Toxicologist
  • Safety Assessor  

 


Publishing

  • Publishing and Submission Specialist
  • Senior Publisher
  • ISI Toolbox Specialist

Regulatory Publishing Software

  • eCTDXpress
  • LIQUENT InSight Publisher
  • ISI Publisher
  • ISI Toolbox
  • LORENZ docuBridge
  • EXTEDO

Document Management Tools

  • CARA
  • Veeva
  • First Doc
  • Global Document Management System
  • Documentum

Validation Tools

  • LORENZ
  • LIQUENT InSight Validator
  • EURS

eCTD Reviewing Tools

  • Rosetta
  • LIQUENT InSight Publisher
  • Global Submit


Medical Devices

  • Device Labeling Specialist
  • Labeling Manager
  • Label Content – QC Specialist
  • Regulatory Affairs Associate
  • Senior Regulatory Affairs Associate
  • Assistance Manager Regulatory Affairs
  • Regulatory Affairs Manager
  • Regulatory Affairs Project Manager
  • Regulatory Affairs Strategist
  • EU - Medical Device Regulation (MDR) Specialist
  • Regulatory Affairs Lead - Post Market Surveillance
  • Clinical Evaluation Report (CER) Specialist
  • Performance Evaluation Report (PER) / Scientific Validation Report Specialist
  • Literature Search Associates / Managers
  • 510(k) Specialist / US Submission Specialist
  • PMA Specialist
  • Device History File Specialist
  • Device Labeling Reviewer
  • CE Marking Specialist / EU Submission Specialist


Regulatory information management

  • XEVMPD Specialist
  • IDMP Solution Specialist