Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Associate Regulatory Professional II
About the department
Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of 8 strong team of high calibre regulatory professionals. The objective of the department is to offer core Regulatory Affairs (RA) competencies enabling NovoNordisk (NN) secure fast, high quality product approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise and work very closely with our colleagues in RAHQ, Denmark (DK) as well as colleagues in our affiliates all over the world. The Regulatory Submissions Team was established in 2014 under GRA-GBS, with a purpose of delivering high quality registration dossiers to our affiliates worldwide and to maintain Novo Nordisk license to operate. The focus area of our department is to provide a superior service to our stakeholders consistently and add value to our submission processes in terms of standardisation and efficiency.
• As an Associate Regulatory Professional II, you will be responsible for d riving operation compilation & delivery of country specific renewals, manufacturing site registration, NDA submissions.
• You will be working on preparing submission operational plan for the upcoming renewals and manufacturing sites submissions based on Regulatory Information Management System (RIMS) & site registration due dates for renewals or based on T- Tool extract for manufacturing sites. Additionally, you will be responsible for creating, manual matching & baselining the submission content plan in Veeva vault RIM (compilation of dossiers in national / eCTD / NeeS & standard format and support in the delivery of required documents by coordinating with various internal & external stakeholders involved.
• Furthermore, for the submission with publishing requirement, you will ensure to raise publishing online form request according to submission size and publishing lead times.
• You will be responsible for ensuring RA system update with approval information within the agreed timelines and handling Q&A from Health Authority within timeline as required.
• In addition to the above, you will support our colleagues in affiliates from across IO regions [LATAM, APAC & SEMEEA] in monitoring the local regulatory environment, ensure overall regulatory compliance and ensure timely submissions with high quality.
• This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management & communication skills. We are looking for candidates who have high ability to articulate regulatory signals and good understanding of local HA requirements.
• Post-Graduation or comparable degree in Science/Pharma/Regulatory Affairs/Quality
• Above 2 years of experience in pharmaceutical industry in Regulatory Affairs
• Basic knowledge on Pharmaceutical Regulatory overview
• Experience inn Regulatory Submission compilation formats & requirements
• Good understanding on Regulatory guidelines
• Good knowledge on Regulatory IT systems & tools
• Basic project management skills
• Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results
• Highly cultural sensitive and comfortable working with different countries and cultures across multiple time-zones
Experience : 2+ years
Qualification : M.Pharm, MSc
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 24th February, 2021
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