Associate Director

1 month ago

Bengaluru, India Novo Nordisk Full time

The position

We are looking for a leadership colleague that can set direction and that have a strong drive to succeed together as a team. As Associate Director, you will have the daily leadership responsibilities for the people in your team and set direction to ensure that we as a team provide best in class regulatory CMC strategies to the projects we support, thereby ensuring fast submissions and approvals globally. You will head up one of the Regulatory Affairs Chemistry Manufacturing & Control (RA CMC) teams consisting of around 12-15 colleagues. Our philosophy is clear: When you thrive and are appropriately challenged in your job, you are the best version of yourself and the most valuable colleague. Being part of an organisation that works as a strategic business partner across various parts of a product’s life cycle, you have exciting opportunities in both the department and across the company and you are expected to carry on this mindset when developing yourself as well as your team. Qualifications To succeed in this role, you have: Leadership experience within pharmaceutical operations or drug development, preferably from Regulatory Affairs. A strong interest in developing people and teams with a proven track record of strong results. Excellent communication skills and are known as a leader who drives change and innovation. Gained formal management training in your career. Required experience in people management. You have demonstrated your ability to lead collaborative teams and have experience with setting directions and motivating people to be ambitious in their work and interaction with stakeholders. You demonstrate a sound business understanding when you develop regulatory strategies. As a person you are ambitious. You have a proactive mindset – you take the lead on overcoming challenges and show your team the way forward. You demonstrate a sound business understanding and you believe in empowering people around you, offering them constructive feedback and guidance to improve their performance. You have a LEAN approach with a focus efficient operation. You are well-organised and have a good strategic focus. You can keep your spirits high even under pressure and as a skilled communicator you can collaborate at across organisational levels. You hold an M Pharma/or Ph.D./Bachelor in Pharmaceutical Sciences or other relevant education and have extensive experience in Global regulatory experience within CMC, including experience with European Medicines Agency (EMA)/European agencies and US Food and Drug Administration (US FDA). About The Department RA CMC & Device BLR, is an integral part of Global RA CMC & Device and comprised of experienced professionals associated with key regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR) and submission of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies and submission activities related to various biotech and rare disease, Diabetes & obesity products and medical devices. We strive to be the best in the industry, delivering safe and innovative products to the patients by strategic business partnering, proactive collaboration with health authorities and efficient operations. Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking “out of the box”, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve. Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -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, 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.

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