Urgent! Regulatory Affairs Manager Nordics - Fixed Term Job Opening In Copenhagen – Now Hiring Norgine
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We have an exciting opportunity for a Regulatory Affairs Manager - Nordics to join Norgine.
The person holding this position will report to Associate Director and be a member of the Regulatory Affairs team.
The core responsibility of the of Regulatory Affairs Manager is to contribute to the growth and expansion of Norgine’s business through partnership with local teams within the Rx and Consumer Health Business Units and global development teams.
They will also be responsible for the co-ordination, planning and interfacing with centrally driven development, lifecycle and labelling activities and through ensuring integration and launch of new assets in the Nordics and for strategic and operational oversight of all regulatory activities associated with the Nordics within the DACH and Nordics cluster and all regulatory development activities associated with those projects under his/her responsibility.
They will also be acting in a capacity on behalf of Norgine Denmark A/S, Azanta A/S, Azanta Denmark A/S, Norgine AS, Norgine Sverige AB and Azanta OY.
This will be a 10-11 month fixed term contract role.
KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
• To be responsible for all product launches, new formulations, integrations for countries in scope
• To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions
• To partner with local stakeholders to ensure co-ordination of approach across products and central strategic positions for country utilisation
• To be the regulatory subject matter expert in area country responsibility
• To manage and lead projects under his/her responsibility
• To represent Regulatory Affairs in the RCU leadership team
• To provide regulatory oversight for country specific submissions
• To support local Pricing & Reimbursement activities
• To provide expert regulatory input for acquisition of products pre-launch & -approval
• To provide advice and recommendations on regulatory strategies
• To provide Regulatory Intelligence, in-country and regional (EMA)
• To provide regulatory support when preparing for and during GxP inspections for countries in scope
• To contribute to oversight of regulatory submissions for DACH & Nordics
• To anticipate and resolve complex regulatory issues independently
• To have budgetary responsibility and oversight for countries in scope
• To provide information on expenditure against budget for inclusion in periodic financial reports
• Where Regulatory input is required by local law or codes; ensuring promotional compliance with legislation and relevant internal/external codes within the relevant RRUs
Requirements
• Good degree in a relevant life science subject or equivalent
• Broad regulatory experience, part of which should have been gained operating at a senior level and general knowledge of worldwide regulatory requirements (including GMP).
• A full strategic understanding of the drug development and life-cycle management principles and processes
• Demonstrates subject matter expertise, e.g. expertise in projects/therapy area/CMC/labelling, or country knowledge
• Ability to communicate clearly in English
• Awareness, understanding and an ability to interpret the ICH guidelines relevant to their technical/functional responsibilities, specifically for the technical/functional responsibilities related to delivering a TPP at the end of the development process
This job description is a summary of the typical functions of the job; not an exhaustive or comprehensive list of all possible responsibilities, tasks and duties.
Norgine reserves the right to change responsibilities to meet business and organisational needs as necessary.
Benefits
Our benefits may vary per location.
Please liaise with the Norgine TA representative to obtain more information.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
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Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide
Real-time Regulatory Affairs Jobs Trends in Copenhagen, Denmark (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Regulatory Affairs in Copenhagen, Denmark using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 39 jobs in Denmark and 20 jobs in Copenhagen. This comprehensive analysis highlights market share and opportunities for professionals in Regulatory Affairs roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Norgine is currently hiring and seeking a Regulatory Affairs Manager Nordics Fixed Term to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Norgine adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Regulatory Affairs Manager Nordics Fixed Term Jobs Denmark varies, but the pay scale is rated "Standard" in Copenhagen. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
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