Associate Director

2 weeks ago

bangalore, India Novo Nordisk AS Full time

Department: Regulatory Affairs CMC and Device

Do you aspire to accelerate your leadership career within a global pharmaceutical company built on life-changing innovations? Does leading a department of incredibly talented and engaged colleagues from diverse cultural and professional backgrounds inspire you? And would you like to be a pivotal and valued business partner bringing our innovative treatments to people who need them? Then you could be one of the candidates we are looking for in the open Associate Director position in RA CMC & Device, to ensure strategic focus and regulatory CMC support.

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 +60 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.

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