RA Artwork Release Coordinator (BB-DCFA9)
Found in: Neuvoo Bulk DK
Job Description20! You will be part of the Regulatory Affairs Department of 20 motivated, knowledgeable and highly skilled RA colleagues. The position is based in our Nordic affiliate located in Copenhagen in Ørestad.
Do you want to get an opportunity to make a difference within a global company in a position that is characterized by high quality, result orientation and speedy realization of the goals? At Sandoz Nordic we have a globally aligned, strategic, efficient and collaborative regulatory function. You will be responsible for release of artwork, upload PIL at DKMA.net, handle regulatory change control in Track Wise, handle Certificate of Pharmaceutical Products. The activities relates to marketing authorisations of Global products (MRP/DCP and CP) in the Nordic countries.
You have an excellent understanding of both the Nordic and European legislation and have the ability to interpret and apply regulations appropriately. You are energetic with positive energy that you like to share with your colleagues; you are self-motivating and thrive in a fast-paced environment. You manage work distribution within given timelines with an appropriate sense of urgency without undermining quality along with working effectively and collaboratively across the organization. You are a self-confident team player, but are also able to work independently to plan, structure and coordinate your tasks. You are a fast learner and are able to handle multiple tasks at the same time. Furthermore, you demonstrate excellent communication skills – written/verbal.
Your responsibilities include, but not limited to:
• Responsible for release of artwork within all therapeutic areas for Global products in the Nordics.
• Close collaboration with labelling/Planning/QA/QC
• Upload PIL at DKMA.net
• Order Certificate of Pharmaceutical Products (CoPP) and send for legalization or Apostille
• Ad hoc proof reading of Mock Ups and package leaflet in accordance with Directives, EU Regulations and national guidelines of PIL and labelling
• Working in compliance with relevant Working Instruction and SOPs as well as current EU and national regulation for the Nordic countries
• Handling of regulatory change controls in TrackWise
• Participate in the on-going development of the department
Minimum requirementsWhat you’ll bring to the role:
• Pharmaconomist or similar preferably with experience from pharmaceutical industry
• Ideally minimum 2-3 years of experience in Regulatory Affairs
• Detail oriented, structured and strong communication skills, mother tongue in one of the Nordic languages and English both verbal and written
• Excellent IT skills
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Group Network here: https://talentnetwork.novartis.com/network
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work SDZ DNK