GSK

Junior Regulatory Specialist (CMC Renewals)

GSKO firmie

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GSK

Grunwaldzka 189

Poznań

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Junior Regulatory Specialist (CMC Renewals)
Workplace: Poznań
251725
Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity). 
 
We are looking for Regulatory Specialist to join CMC Renewals Poznan team. In this role You will be accountable for the CMC renewals delivery  in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licences worldwide. You will have an opportunity to work closely with GRPD’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRPD’s goals.

 

Key responsibilities:

  • Manage multiple renewals assignments, define and agree strategy, complete data assessment to ensure authored CMC dossier fits for purpose, 
  • Communicate regularly with Your line manager to help identify any issues with business impact 
  • Ensure information submitted in marketing applications meets regional requirements, allowing maximum flexibility with minimal unanticipated questions.
  • Interact and work with global regulatory groups, Global Manufacturing & Supply and GSK Local Operating Companies to deliver high quality dossier (right first time) on time
  • Monitor regulatory intelligence and act proactively on identified changes to regulatory requirements
  • Build and maintain good relationships with your internal and external stakeholders 

Basic qualifications:

  • Minimum Bachelor’s degree in biotechnology, biology, chemistry, pharmacy or other related science or technical field
  • Excellent written and verbal communication skills in English.
  • Attention to detail, excellent organization and time management skills. 
  • Ability to think flexibly to meet shifting priorities and timelines and to independently provide solutions to issues.
  • Strong will to learn new things
  • Ability to organize your own work schedule and to keep deadlines  

We offer:

  • Established job in international, well-known pharmaceutical company
  • Wide range of benefits (Medical Plan, Life Insurance, Sport and recreation cards, Recreation allowance etc.)
  • Annual bonus
  • Possibilities of development within the role and company’s structure
  • Opportunity to work within GSK standards and documentation applied globally
  • Canteen for employees at site (with discounts)
  • Flexible working hours
  • Partly remote work
 


 

 

Junior Regulatory Specialist (CMC Renewals)Numer ref.: 251725
Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity). 
 
We are looking for Regulatory Specialist to join CMC Renewals Poznan team. In this role You will be accountable for the CMC renewals delivery  in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licences worldwide. You will have an opportunity to work closely with GRPD’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRPD’s goals.

 

Key responsibilities:

  • Manage multiple renewals assignments, define and agree strategy, complete data assessment to ensure authored CMC dossier fits for purpose, 
  • Communicate regularly with Your line manager to help identify any issues with business impact 
  • Ensure information submitted in marketing applications meets regional requirements, allowing maximum flexibility with minimal unanticipated questions.
  • Interact and work with global regulatory groups, Global Manufacturing & Supply and GSK Local Operating Companies to deliver high quality dossier (right first time) on time
  • Monitor regulatory intelligence and act proactively on identified changes to regulatory requirements
  • Build and maintain good relationships with your internal and external stakeholders 

Basic qualifications:

  • Minimum Bachelor’s degree in biotechnology, biology, chemistry, pharmacy or other related science or technical field
  • Excellent written and verbal communication skills in English.
  • Attention to detail, excellent organization and time management skills. 
  • Ability to think flexibly to meet shifting priorities and timelines and to independently provide solutions to issues.
  • Strong will to learn new things
  • Ability to organize your own work schedule and to keep deadlines  

We offer:

  • Established job in international, well-known pharmaceutical company
  • Wide range of benefits (Medical Plan, Life Insurance, Sport and recreation cards, Recreation allowance etc.)
  • Annual bonus
  • Possibilities of development within the role and company’s structure
  • Opportunity to work within GSK standards and documentation applied globally
  • Canteen for employees at site (with discounts)
  • Flexible working hours
  • Partly remote work
 
 

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