Associate Regulatory Specialist
3 weeks ago
Department: Regulatory Affairs Rare Endocrine Disorders
Job Level: 7
Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies?
We are looking for a skilled colleague who will be instrumental in supporting regulatory processes in the most efficient way.
If you are detail-oriented, have strong communication skills, and are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.
The Position
As a Associate Regulatory Specialist at Novo Nordisk, you will have the following responsibilities:
Responsible for all regulatory submissions to Health Authorities worldwide including Submission Planning, Regulatory File Preparation, Submission Management, Communication & Archiving. Plan and conduct regulatory interactions with health authorities, including preparing meeting requests, packages, and taking meeting minutes. Link business opportunities and key differentiators from the Target Product Profile (TPP) to core labeling. Develop and maintain target eCCDS/CCDS, European labeling, and support US labeling development. Establish and maintaining core labelling Act as an expert in RA processes, RA due diligence, and RA clinical mattersQualifications
To be successful in this role, we are looking for a candidate with the following qualifications:
Preferred Master of Science (life sciences) relevant experience and/or PhD with 9+ years of relevant regulatory experience Thorough understanding of regulatory science and requirements across various regions including EU, US, China, Japan, and others. Experience in life cycle management, label development, health authority interactions, and device development. Proficiency in regulatory intelligence and therapeutic area knowledge. Demonstrated project management skills. Understanding of business management and the R&D value chain in the pharmaceutical industry. Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology. Knowledge of patient access, real-world evidence, and proficiency in written and spoken English.About the department
The Regulatory Affairs department plays a vital role in ensuring the compliance of Novo Nordisk’s medicines and devices. Our team works closely with regulatory authorities and internal stakeholders to navigate the complex regulatory landscape and bring innovative products to market. We value diversity and expertise, creating a collaborative and multi-disciplinary environment where professionals from various backgrounds come together to make a difference. Join us and be part of a team that is dedicated to improving patient lives.
Working At Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.
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