GSK Services

Regulatory Specialist

GSK ServicesO firmie

GSK Services

Grunwaldzka 189

Poznań

We have more than 100 000
working towards 1 common
purpose: access to healthcare
for all.
How will you help us achieve it?

To challenge, To change,
more you will find on
gsk.com/pl/kariera
GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.
 
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, labeling 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).
 
In this role you have an opportunity to work closely with GMS Programs Team that is in place to support significant Global Manufacturing and Supply (GMS) centrally driven change programs.  The Team provides dedicated support to ensure regulatory changes for key GMS initiatives are progressed timely and efficiently.  The Team is responsible for preparation of a technical documentation for regulatory changes globally, providing a response to Regulatory Agency questions and expertise in the regulatory requirements for global source changes/CMC variations on Active Pharmaceutical Ingredients (API), Intermediates and Drug Product as well as other GMS initiatives.
 
If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone’s life, then this opportunity is for you.
Regulatory Specialist
Workplace: Poznań
241950

In your new role you will:

  • manage routine assigned projects, analyze the strategy with own input, and provide comprehensive data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and local markets’ requirements,
  • deliver multiple challenging source changes on API, Intermediates and Drug Product and other programs driven by GMS including Wave 1 submissions,
  • communicate regularly with Regulatory Manager to help in identification of any issues with business impact,
  • identify improvement opportunities for CMC Regulatory processes, policies and systems,
  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
  • interact with global regulatory groups and GSK Local Operating Companies in markets worldwide to deliver compliant and timely dossiers,
  • build and maintain good relationships with your internal and external stakeholders,
  • have training and mentoring responsibilities.

Requirements:

  • approximately 2 years of experience in pharmaceutical industry and regulatory affairs,
  • Bachelors degree in chemistry, pharmacy or other related science or technical field,
  • fluent Polish and English (both verbal and written),
  • ability to handle multiple tasks to prioritize and schedule work to meet business needs,
  • flexible and analytical thinking to independently provide solutions to issues,
  • detail-oriented, with emphasis on accuracy and completeness,
  • excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization.
  • understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

We offer:

  • Established job in an international, well-known pharmaceutical company
  • Opportunity to work in a professional team playing crucial role in introducing GSK portfolio to the market
  • Opportunity to work within GSK standards and documentation applied globally
  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance)
  • Annual bonus
  • Canteen for employees at site (with discounts)
  • Partly remote work
  • Flexible working hours

You are invited to submit your application using the “Apply now” button.

Thank you very much for your interest in development opportunities with GlaxoSmithKline.



 Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.
 
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, labeling 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).
 
In this role you have an opportunity to work closely with GMS Programs Team that is in place to support significant Global Manufacturing and Supply (GMS) centrally driven change programs.  The Team provides dedicated support to ensure regulatory changes for key GMS initiatives are progressed timely and efficiently.  The Team is responsible for preparation of a technical documentation for regulatory changes globally, providing a response to Regulatory Agency questions and expertise in the regulatory requirements for global source changes/CMC variations on Active Pharmaceutical Ingredients (API), Intermediates and Drug Product as well as other GMS initiatives.
 
If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone’s life, then this opportunity is for you.
Regulatory SpecialistNumer ref.: 241950

In your new role you will:

  • manage routine assigned projects, analyze the strategy with own input, and provide comprehensive data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and local markets’ requirements,
  • deliver multiple challenging source changes on API, Intermediates and Drug Product and other programs driven by GMS including Wave 1 submissions,
  • communicate regularly with Regulatory Manager to help in identification of any issues with business impact,
  • identify improvement opportunities for CMC Regulatory processes, policies and systems,
  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
  • interact with global regulatory groups and GSK Local Operating Companies in markets worldwide to deliver compliant and timely dossiers,
  • build and maintain good relationships with your internal and external stakeholders,
  • have training and mentoring responsibilities.

Requirements:

  • approximately 2 years of experience in pharmaceutical industry and regulatory affairs,
  • Bachelors degree in chemistry, pharmacy or other related science or technical field,
  • fluent Polish and English (both verbal and written),
  • ability to handle multiple tasks to prioritize and schedule work to meet business needs,
  • flexible and analytical thinking to independently provide solutions to issues,
  • detail-oriented, with emphasis on accuracy and completeness,
  • excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization.
  • understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

We offer:

  • Established job in an international, well-known pharmaceutical company
  • Opportunity to work in a professional team playing crucial role in introducing GSK portfolio to the market
  • Opportunity to work within GSK standards and documentation applied globally
  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance)
  • Annual bonus
  • Canteen for employees at site (with discounts)
  • Partly remote work
  • Flexible working hours

You are invited to submit your application using the “Apply now” button.

Thank you very much for your interest in development opportunities with GlaxoSmithKline.

 Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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