21 Jun

Regulatory Affairs Officer Ledige Stillinger på Sandoz København

Stilling
Regulatory Affairs Officer
Selskab
Sandoz
Beliggenhed
København D84
Er åbningsdato
21 Jun, 2018 30 days ago

Sandoz København presserende behov efter position for Regulatory Affairs Officer. Læs denne jobannonce grundigt før ansøger om jobbet. Der er nogle kvalifikationer, erfaringer og kvalifikationsbehov, at arbejdsgiverne kræver. Er din karriere historie passer disse krav? Sørg for at du forstår den rolle, du søger, og at det er egnet til dine evner og kvalifikationer.

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Regulatory Affairs Officer Ledige Stillinger på Sandoz København Detaljer Job:

Job Summary:
Great opportunity to work for a global generics leader as Regulatory Affairs Officer, Nordic

Job Purpose:
Sandoz is looking for a professional and highly motivated Regulatory Affairs Officer with solid knowledge and experience working with life cycle management (LCM) of our marketing authorizations with responsibility within own Therapeutic Areas.

Sandoz offers a challenging position within a dedicated company characterized by high quality, result orientation and speedy realization of the goals. At Sandoz we have a globally aligned, strategic, efficient and collaborative regulatory function.

Key Responsibilities:
As a RA Officer your main task is related to:
  • Maintenance (LCM) and ensuring regulatory compliance of marketing authorizations
  • Safety updates/text management of national texts including preparation
  • Prepare and ensure timely submission of national texts and mock-ups for Global products (MRP/DPC and CP) in the Nordics within own Therapeutic Areas
  • Respond to request from the authorities within given deadline
  • Participate in implementation of new structure with e-2-e ownership in RA LCM Global Product team.
  • Cross functional planning and corporation with (RCC-EU) Regulatory Competence Center in Germany and the Netherlands on variations and renewals
  • Participate in collaboration with Supply Chain/Planning/labelling/QA/QC with increased focus on business partnership
  • Review and approval of Product Specific Annex (PSA) and Pre Launch Check List (PLC)
  • Updating of relevant databases (SAP and Access)
  • Regulatory handling of change controls and deviations in TrackWise
  • Knowledge about national and EU legislation within the regulatory field.
  • Ensure compliance with regulatory guidelines

About Sandoz:
Sandoz, a Novartis Division, is a global leader in generic pharmaceuticals and biosimilars. Sandoz's purpose it to discover new ways to improve and extend people’s lives and pioneer novel approaches to help people around the world access high-quality healthcare. Sandoz supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2 billion.

In Sandoz Nordic you will find a dynamic and performance oriented culture with around 160 passionate people supporting the Danish, Swedish, Finnish, Norwegian and Icelandic Markets.
Our Head office is located in Copenhagen and together with Novartis Healthcare and Alcon, and we also have offices in Stockholm, Helsinki and Oslo.

Culture and Values
Sandoz has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation. Our values help guide the choices people make every day, and they define our culture and help us execute the Sandoz strategy in line with our mission and vision.

Our values and behaviors are:
Innovation - by experimenting and delivering solutions
Quality - by taking pride in doing ordinary things extraordinarily well
Collaboration - by championing high performing teams with diversity and inclusion
Performance - by prioritizing and making things happen with urgency
Courage - by speaking up, giving and receiving feedback
Integrity - by advocating and applying high ethical standards every day

Benefits of Working for Sandoz:
  • A Competitive Salary package with fixed salary, bonus, pension and health insurance
  • “Be Healthy” initiatives to promote associate health and prevent future health issues
  • Flexible working hours and possibility to work from home
  • A high paced, dynamic and performance-oriented environment with competent and committed colleagues.
  • At Sandoz, we encourage personal and professional development and the opportunity to make a career internally at Sandoz, Alcon or Novartis Healthcare

‘I came for the job, I stay for the culture’

Minimum requirements

The ideal candidate:
You are newly graduated with excellent results B.Sc. in Pharmacy or have a M.Sc. degree in life science combined with 1-3 years of professional experience within regulatory affairs. You have a knowledge of both the Nordic and European regulatory requirements and have the ability to interpret and apply regulations appropriately.
You are energetic, passionate and enthusiastic and thrive in a fast-paced environment and are able to meet timelines reliably and without undermining quality along with working effectively and collaboratively across the organization. You are self-confident, a strong and pro-active teamplayer, but are also able to work independently to plan, structure and coordinate your tasks. You are a fast learner and is able to handle multipe tasks at the same time. Furthermore, you demonstrate excellent communication skills – both written and verbal – and are fluent in at least one of the Nordic languages (preferred mother’s tongue) as well as English. Languages skills within other Nordic country languages are an advantage.

#LI-DNI

Sandoz is an equal opportunities employer and welcomes applications from all suitably qualified persons.

We kindly ask you to apply with an English version of your CV and if shortlisted you can expect a call from an international number.

Division

SANDOZ

Business Unit

Commercial Ops SZ

Country

Denmark

Work Location

Copenhagen

Company/Legal Entity

SDZ DNK

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular


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