Job Description

Department: RA CMC
Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as \xe2\x80\x9cSenior Regulatory Professional\xe2\x80\x9d with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.
About the department
Regulatory Affairs CMC plays an important role in ensuring all Novo Nordisk Medicines and Devices developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product development, NDA and maintenance of LCM activities. Our people in Regulatory Affairs come from diverse academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to reach the markets. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.
The Position
As Senior Regulatory Professional, the candidate will use Subject Matter Expertise to solve business issues and arrive at a solution. The ideal candidate will be responsible for planning and strategic execution of various life cycle maintenance activities for global markets along with creation and routine maintenance for Module 3 CMC quality documents. One should have demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. The professional will be required to handle most situations independently while extending support to junior colleagues. Further responsibilities include handling the change requests & query response received from the affiliates around the globe.

• Support submission planning: Apply intelligence and develop Regulatory strategy. Create and maintain Regulatory Affairs Submission Plan and create/review Module 3 CMC documents.
• Support preparation of Regulatory file followed by co-ordination for Publishing and Distribution of Dossier.
• Support submission of Regulatory files, Response to questions from Health Authorities and maintenance of Marketing Authorization globally.
• Contacts and consults with global regulatory authorities including FDA and EMA/national agencies in accordance with line management.
• Defined standard CMC variation applications (e.g. Additional manufacturing site, extension of product shelf life, new cell banks).

The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders.
Qualifications

• 8+ years of experience within Regulatory affairs with Graduate /

Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine.

• Experience of working both in Global & Affiliate environment will be preferred.
• Experience from working with European medicines agencies and with US FDA.
• Mentoring within the team as and when required.
• Good understanding of end-to-end Regulatory processes and Life Cycle

Management.

• Bold and strong personality with proven negotiation skills.
• Should be able to convince and put forward the facts confidently- negotiation skills required.
• Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
• High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
• Excellent written/spoken communication skills.

Working At Novo Nordisk At Novo Nordisk we don\xe2\x80\x99t wait for change, We drive it. We\xe2\x80\x99re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never miss the opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales- we\'re all working to move the needle on patient care.
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: 4th May, 2023
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\xe2\x80\x99re life changing.