Junior Regulatory Specialist

  • Poznań, wielkopolskie pokaż mapę
  • Specjalista
  • 21.12.2017
  • Ważna jeszcze 0 dni (do 20.01.2018)

Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

Every year 6.2 million children
die from preventable diseases.
Your skills can help them
to thrive not just to survive.

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 group who deliver Supply Chain Transformation and major programmes being driven by GMS that are vital to our success as we continue to seek opportunities to simplify and drive compliance.

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.

Junior Regulatory Specialist
Location: Poznań
WD150452

In your new role you will:

  • take part in a challenging projects related to the API and DP source transfers and other programs driven by GMS,
  • support the Team in multiple regulatory activities and in preparation of appropriate CMC modules and variation dossiers for GSK pharma products,
  • acquire knowledge of regulations, guidelines, procedures and policies relating to the registration and manufacturing of pharmaceutical products,
  • communicate regularly with Regulatory Manager/Team Lead to help in identification of any issues with business impact,
  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
  • interact with global regulatory groups and local operating companies to deliver compliant and timely dossiers,
  • build and maintain quality relations with your internal and external stakeholders.

Basic requirements:

  • Bachelor’s degree in chemistry, pharmacy or other related science or technical field,
  • fluent Polish and English (both verbal and written),
  • ability to handle multiple tasks and to prioritize and schedule work to meet business needs,
  • flexible and analytical thinking,
  • 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.

Additional requirements:

  • work experience in an international environment would be an additional advantage,
  • strong computer related skills (including Microsoft Office).

We offer the opportunity to gain experience in well-known company, to cooperate with international environment where you can have an access to cutting-edge technology and work in friendly atmosphere. We provide an attractive remuneration package and benefits, as well as the prospects of a comprehensive professional development.

Closing date for applications: 21/01/18

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.