Post : Regulatory Affairs Analyst
As Regulatory Affair (RA) Associate Analyst, you will be responsible for compiling and supporting the submission of manufacturing sites globally. Your key responsibilities are facilitation of submission planning meetings with RA colleagues in different countries, compilation of national table of contents, table of contents (TOCs) based on the countries’ local requirements, coordination of registration sample and follow up with RA affiliates on final submission to health authority.
You will be delivering high quality registration dossiers, which require a good understanding of regulatory guidelines, regulatory Chemistry, Manufacturing and Control (CMC) documentation, different registration file formats and the Regulatory dossier compilation process.
The job involves close collaboration with global regulatory teams in Denmark and Bangalore, as well as Novo Nordisk affiliates across the globe to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role. Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority. .
• You have a post graduate education in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs for 3-5 years in handling eCTD/NeeS/National format dossier & Table of content compilation for different markets (US/EU & Rest of the World).
• As a person, you thrive in a busy environment and you bring a can-do attitude. You’re a strong team player, but you also enjoy working independently.
• You are a skilled communicator, who can collaborate with a lot of stakeholders and comfortable using your excellent written and spoken English proficiency daily. Furthermore, you have flair for IT systems and experience with MS Office.
• We expect you to be a good planner, well organised, service minded, positive, engaged and actively contribute to a good team spirit.
Qualification : M.Pharm, M.Sc
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 1st April, 2019