Senior/ Regulatory Submissions Specialist - Full Time - Remote

at  Meet Recruitment

United Kingdom, , United Kingdom - 00000

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate08 Jul, 2022Not Specified09 Mar, 20222 year(s) or aboveEthics,Regulatory Requirements,Regulatory Affairs,Management SkillsNoNo
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Description:

Our client is a mid-size European CRO looking for a Senior / Regulatory Submissions Specialist to join their growing Study Start Up team in the UK. As the Study Start Up / Regulatory Submissions Specialist you will be responsible for the realisation of all aspects of Clinical Study Registration to the relevant Ethics Committee’s and Regulatory Authorities in assigned Countries.

SKILLS REQUIRED

Responsibilities:

  • Prepare regulatory documents and adapt regulatory submission packages to the Competent Authority and Ethics Committee(s)
  • Review local clinical study application and amendment submission packages of assigned country/ies
  • Ensures that regulatory deliverables for the assigned country/ies and/or projects are on time and with quality
  • Supports development of country regulatory intelligence data related to clinical study application and amendment submissions to Competent Authorities and Ethics Committees
  • Identifies project and/or country specific problems and risks related to clinical study applications and amendments to Competent Authorities and Ethics Committees and works with internal and external team members to provide and implement solutions

Desired Skills:

  • Minimum of Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree preferred
  • Minimum of 2 years of experience in Regulatory Affairs and SSU work or related work in a Clinical Research environment
  • Very good knowledge of ICH/GCP guidelines, local regulatory requirements, European regulations and Standard Operating Procedures
  • Very good understanding of clinical trial registration process in the assigned country/ies
  • Advanced organizational and time management skills in order to balance working on multiple projects in parallel

Responsibilities:

  • Prepare regulatory documents and adapt regulatory submission packages to the Competent Authority and Ethics Committee(s)
  • Review local clinical study application and amendment submission packages of assigned country/ies
  • Ensures that regulatory deliverables for the assigned country/ies and/or projects are on time and with quality
  • Supports development of country regulatory intelligence data related to clinical study application and amendment submissions to Competent Authorities and Ethics Committees
  • Identifies project and/or country specific problems and risks related to clinical study applications and amendments to Competent Authorities and Ethics Committees and works with internal and external team members to provide and implement solution


REQUIREMENT SUMMARY

Min:2.0Max:7.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

A scientific or technical discipline advanced degree preferred

Proficient

1

United Kingdom, United Kingdom