Regulatory Specialist(M/F/d) - Dresden, Deutschland - GSK

GSK
GSK
Geprüftes Unternehmen
Dresden, Deutschland

vor 1 Monat

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

Site Name:
Dresden - Office


Posted Date:
May

**_

Be You' at GSK_**GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

We are looking for you at our Production Site in Dresden as a


Regulatory Specialist (M/F/d)
In Fulltime and Permanent/ Fixed Term basis


The role


Supports Global Regulatory submission by efficiently coordinating the preparation, compilation and/or management of official documents (certificates and legalized) and other market specific requirements required by the local (regulatory) Health Authorities to enable new product registration and licenses maintenance submission, with mínimal input from manager.

Develop and implement adequate strategies and guidance to established departmental processes. Pro-actively identify and implement process improvements to drive efficiency and ensure business continuity.


Your key responsibilities will be the following:

  • Issuing CPPs (Certificate of pharmaceutical product) (WHO Certificate with composition, SmPC and other required documents, e.g. package instruction) for products which are licensed by GSK Germany
  • Updated product data details checked in Veeva Vault before CPP is issued
  • Manages multiple project assignments simultaneously: Coordinate Notarization and Embassy legalization of documents including but not limited to CPP, GMP, ML and other Regulatory documents.
  • Chase-Up to ensure latest status of outstanding documents is known.
  • Assistance in the creation of approvalrelevant documents.
  • Dealing and filling correspondence in German and English, including conducting telephone calls.
  • Understands internal/external Regulatory environment.
  • Actively builds an organizational network.
  • With mínimal input from manager, identifies risks associated with submission data and information packages.
  • Communicate with line manager and/or across GSK regarding project, policy issues or to identify issues that have business impact to ensure optimum position for GSK.

_ Why You? _

Basic qualifications:


  • Degree in scientific discipline (life sciences / pharmacy / professions aligned to medicine) preferred
  • Multiple years of relevant experience in Regulatory Affairs
  • Knowledge of the policies and regulatory climate in Europe
  • Experience gained across various markets is preferred
  • Experience of working effectively in a matrix across functions
  • Fluent English and German language skills (written and spoken)
  • Able to effectively collaboration and negotiation with regulatory agencies

_ Why GSK?_

  • Attractive compensation within the Tariffs (Chemie Ost)
  • Working in an international environment while being connected with other international GSK locations
  • Working in a company that contributes to the improvement of people's health
  • Working with an engaging team of experts with different specializations
  • A variety of growth and development programs
  • Company events
  • Working within the city center of Dresden with great transport connections and access to restaurants and shopping possibilities
  • Career at one of the leading global healthcare companies
  • Supportive & friendly working environment


GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the
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