GSK

Senior Regulatory Specialist (Facilities)

GSKO firmie

GSK

Grunwaldzka 189

Poznań

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The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznań team. The purpose for the role will be leading or participating in global CMC Facilities Variation projects for vaccines products, timely maintenance of post approval CMC Facilities changes for Finished Product and Active Pharmaceutical Ingredients, providing expertise and support to Global Regulatory Affairs team with respect to post approval changes and responses to Regulatory Agency questions about Products.

Senior Regulatory Specialist is involved in the company’s regulatory activities related to new and existing vaccines products, on an international basis. Activities focus on technical writing for Facilities major and minor submissions.

Senior Regulatory Specialist (Facilities)
Location: Poznań
job No. 228019

Key responsibilities:

  • Write CMC, “facility and equipment” parts and new files for WW regulatory Files
  • Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion
  • Ensure the coordination with the departments involved in the writing/review process
  • Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities
  • Monitor that supportive data provided by other departments are available and compliant
  • Report significant issues
  • Manage the projects within all GSK/GRA tracking tools

Basic requirements:

  • Experience in writing CMC (technical) parts of regulatory documents (registration files or variations)
  • Relevant experience working in validation/QA/production in Biologics/Pharmaceuticals industry
  • Bachelor’s or Master's degree in pharmacy, biotechnology, chemistry or other related science or technical field
  • Knowledge of regulatory procedures / systems / guidances
  • Fluent English (spoken and written)
  • Knowledge of biologic process and process equipment.
  • Knowledge of Qualification/ Validation principles.
  • Attention to details, excellent organization and time management skills
  • Excellent communication skills
  • Writing skills
  • Analytical skills, creative and critical mind
  • Ensures the coherence between contributions / quality of final results
  • Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
  • Team player

Additional preferred qualifications:

  • Good level of written French or German or Italian will be a strong asset

Why GSK?:

  • Established job in an international, well-known pharmaceutical company
  • Possibilities of development within the role and company’s structure
  • Wide range of benefits (Medical Plan, Life Insurance, Sport and recreation cards, Recreation allowance etc.)
  • Canteen for employees at site (with discounts)
  • Flexible working hours
  • Partly remote work
  • Corporate culture based on our values: patient focus, integrity, respect and transparency


 


Poznań
Business Garden
 

The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznań team. The purpose for the role will be leading or participating in global CMC Facilities Variation projects for vaccines products, timely maintenance of post approval CMC Facilities changes for Finished Product and Active Pharmaceutical Ingredients, providing expertise and support to Global Regulatory Affairs team with respect to post approval changes and responses to Regulatory Agency questions about Products.

Senior Regulatory Specialist is involved in the company’s regulatory activities related to new and existing vaccines products, on an international basis. Activities focus on technical writing for Facilities major and minor submissions.

Senior Regulatory Specialist (Facilities)Numer ref.: job No. 228019

Key responsibilities:

  • Write CMC, “facility and equipment” parts and new files for WW regulatory Files
  • Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion
  • Ensure the coordination with the departments involved in the writing/review process
  • Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities
  • Monitor that supportive data provided by other departments are available and compliant
  • Report significant issues
  • Manage the projects within all GSK/GRA tracking tools

Basic requirements:

  • Experience in writing CMC (technical) parts of regulatory documents (registration files or variations)
  • Relevant experience working in validation/QA/production in Biologics/Pharmaceuticals industry
  • Bachelor’s or Master's degree in pharmacy, biotechnology, chemistry or other related science or technical field
  • Knowledge of regulatory procedures / systems / guidances
  • Fluent English (spoken and written)
  • Knowledge of biologic process and process equipment.
  • Knowledge of Qualification/ Validation principles.
  • Attention to details, excellent organization and time management skills
  • Excellent communication skills
  • Writing skills
  • Analytical skills, creative and critical mind
  • Ensures the coherence between contributions / quality of final results
  • Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
  • Team player

Additional preferred qualifications:

  • Good level of written French or German or Italian will be a strong asset

Why GSK?:

  • Established job in an international, well-known pharmaceutical company
  • Possibilities of development within the role and company’s structure
  • Wide range of benefits (Medical Plan, Life Insurance, Sport and recreation cards, Recreation allowance etc.)
  • Canteen for employees at site (with discounts)
  • Flexible working hours
  • Partly remote work
  • Corporate culture based on our values: patient focus, integrity, respect and transparency


 
 
Poznań
Business Garden

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