Job Description

By continuing to use and navigate this website, you are agreeing to the use of cookies.
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...CategorySelect how often (in days) to receive an alert:\xc3\x97Select how often (in days) to receive an alert:Senior Regulatory Professional - RA OCECategory: Reg Affairs & Safety PharmacovigilanceLocation:Bangalore, Karnataka, INJob Title: Senior Regulatory ProfessionalDepartment: Operational Centre of Excellence (OCE)About the departmentOperational Centre of Excellence also known as OCE is a part of IOSO RA Bangalore, OCE was established in May 2021. The main objective of OCE is to extend their expertise to affiliates to absorb their increasing workload by taking on end-to-end tasks. Operational Centre of Excellence (OCE) in Bangalore will be responsible for providing regulatory technical support for NDA & LCM activities in Regions APAC & SEEMEA.The OCE has a broad range of countries in its portfolio, which enables it to comprehend the constantly changing regulatory environment and fosters the sharing of ideas and best practices across markets.Are you passionate about your work? 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.The Position

• Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries. (NDA, LCM & post approval changes)
• Support affiliate in reviewing labelling materials and promotional materials if required.
• Support affiliate in updating local requirements based on regulatory agencies guidance and input from affiliates / distributers.
• Managing working relationships with key stakeholders.

Qualifications

• Graduate / Postgraduate in Science / pharmacy / medicine / relevant.
• Excellent knowledge on Pharmaceutical Regulatory overview.
• Excellent understanding on Regulatory guidelines & landscape.
• Excellent knowledge on Regulatory IT systems & tools.
• Excellent knowledge within regulatory affairs and extensive cross functional business understanding.
• Fluent in written and spoken English.
• Intermediate Project management skills & knowledge on MS Office.
• Excellent Communication & negotiation skills.
• Good understanding on R&D Value Chain and pharmaceutical industry.

Working at Novo NordiskNovo 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.ContactIf you believe you are a match for the above requirements and are highly motivated to take up the role, please apply here with our online application tool.DeadlineApply 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.

Novo Nordisk