Department: Regulatory Affairs Rare Blood Disorders
Job Level: 6
Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight deadlines and many stakeholders
We are looking for a Senior Regulatory Professional to join our Regulatory Affairs team at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.
The Position
As a Regulatory Professional, you are expected to demonstrate leadership by setting the regulatory strategy and being responsible for planning, preparing, and submitting high quality files to the health authorities achieving fast approvals. You will work as an integrated part of global cross-functional teams with stakeholders ranging from safety, medical affairs, commercial to our Novo Nordisk affiliates worldwide. As part of our department, you will be responsible for planning and driving regulatory activities and deliverables according to agreed timelines and quality. You will be accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory approvals globally. You must demonstrate subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to global Life Cycle Management activities.
Furthermore, in the role you will also handle: -
- Compile, review, submit pre-meeting packages for authority meetings and Handle change requests.
- Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide.
- Plan and conduct regulatory interactions with health authorities, including preparing meeting requests, packages, and taking meeting minutes.
- Pharmacovigilance documentation like Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Risk Management Plan (RMP), renewals, post approval changes.
- Handle Life Cycle Management (LCM) of the product, keeping the product live- clinical file protocols and Interim study reports.
Qualifications
To be successful in this role, we are looking for a candidate with the following qualifications:
- 6+ years of experience in related field along with Post Graduate Degree in Life Sciences is required.
- International Work experience or previous experience with working in a global setting will be preferrable.
- Experience in handling life cycle management of product and clinical regulatory submissions is required.
- Thorough understanding of regulatory science and requirements across various regions including EU, US, China, Japan, and others.
- Experience in label development, health authority interactions, and device development.
- Proficiency in regulatory intelligence and therapeutic area knowledge.
- Demonstrated project management skills. Excellent communication, negotiation, and presentation 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 at Novo Nordisk plays a crucial role in ensuring compliance and patient safety. Our team works closely with relevant authorities and stakeholders throughout the product development lifecycle. With diverse academic and professional backgrounds, our team brings valuable insights and expertise to the table. We offer excellent opportunities for professional development and career growth in a dynamic and challenging environment.
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. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.
Contact
If 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.
Deadline:
Apply on or before: 7th June 2024
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, we're life changing.
