Job Description

Department: RA Semaglutide and GLP-1, Global Regulatory AffairsAre you passionate about ensuring regulatory compliance for patient focused products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisks 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 positionAs a Senior Regulatory Professional 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 and handling all the life cycle related activities.
• Plan and conduct regulatory interactions with health authorities, including preparing meeting requests, packages, and taking meeting minutes.
• Participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications to EU and other regions as applicable, clinical trial protocols and reports and regulatory files for marketing authorization, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation.
• Link business opportunities and key differentiators from the Target Product Profile (TPP) to core labeling. Develop and maintain target CCDS/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 matters.

QualificationsTo 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 departmentThe Regulatory Affairs department plays a vital role in ensuring the compliance of Novo Nordisks 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 NordiskAt Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.ContactIf you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.DeadlineApply on or before: 20th August 24DisclaimerIt has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, were life changing.

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