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Offered Associate Director,

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Job Specifications
Employment Type Full time jobs
Job Description

Department: RA CMC and Device D and O : Bangalore
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 and Device : D and O, to ensure strategic focus and regulatory CMC support. Apply Now
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. You will head up one of the Regulatory Affairs Chemistry Manufacturing and Control (RA CMC) teams consisting of around 7 colleagues located in both Bangalore, India, and in S borg, Denmark. We are working in a hybrid organization where the direct manager is in Denmark.
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 organization 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 continue this mindset when developing yourself as well as your team. The position is based in Bangalore, India.
Qualifications
To succeed in this role, you have:
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You hold an M Pharma/or Ph.D./Bachelor in Pharmaceutical Sciences or other relevant education. Overall 12 years of extensive regulatory or MSAT experience within CMC, including experience with European Medicines Agency (EMA)/European agencies and US Food and Drug Administration (US FDA).
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4:5 years of leadership experience within pharmaceutical operations or drug development, preferably from Regulatory Affairs or MSAT (Manufacturing Development).
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International leadership experience, ideally with experience managing in a hybrid setup.
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A strong interest in developing people and teams with a proven track record of strong results.
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Excellent communication skills and are known as a leader who drives change and innovation.
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Gained formal management training in your career.
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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.
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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:organized 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 organizational levels.
About The Department
RA CMC and Device D and O BLR, is an integral part of Global RA CMC and 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 and Obesity products, and medical devices. We strive to be the best in the
Job Type: Permanent
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TipTopJob (Registered since June-2013)
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