Regulatory Affairs Officer
COMMERICAL OPS WE SZ
Research & Development
The open position is located in the Global RA Life Cycle Management team covering a portfolio that consist of marketing authorizations maintained within Sandoz. The life cycle activities relates to marketing authorizations (MRP/DCP and CP) in the Nordic countries. You will work from the Office located in Finland together with a dedicated colleague and you will be part of the RA LCM Global product team working from the office located in Copenhagen close to the airport. Travelling to Denmark is estimated to be 1-2 days monthly.
The purpose of the Regulatory Affairs Officer role is:
• Life Cycle Management on MAs in the Nordic countries in cooperation with RCC-EU
• Identification and implementation of appropriate Nordic regulatory strategies
• Expert on regulatory requirements in the Nordic countries
• Maintenance and ensuring regulatory compliance of marketing authorizations
• 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
• Participate in implementation of new structure with e-2-e ownership in RA LCM Global Product team.
• Prepare and ensure timely submission of national texts and mock-ups for Global products (MRP/DPC and CP) in the Nordics within own Terapeutic Areas
• Respond to request from the authorities within given deadline
• Safety updates/text management of national texts including preparation
• 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
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.
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 will have:
- You are graduated with excellent results B.Sc. in Pharmacy or have a M.Sc. degree in life science combined with 2-5 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 team player, but are also able to work independently to plan, structure and coordinate your tasks.
- You are a fast learner and is able to handle multiple 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.
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.