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Novo Nordisk hiring Senior Regulatory Professional at Bangalore
Senior Regulatory Professional
Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN
Department: Regulatory Affairs Rare
Endocrine Disorders Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies?We are looking for a skilled colleague who will be instrumental in supporting regulatory processes in the most efficient way.If you are detail-oriented, have strong communication skills, and are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.
The Position
As a Senior Regulatory Professional at Novo Nordisk, you will have the following responsibilities:Responsible for all regulatory submissions to Health Authorities worldwide including Submission Planning, Regulatory File Preparation, Submission Management, Communication & Archiving.Plan and conduct regulatory interactions with health authorities, including preparing meeting requests, packages, and taking meeting minutes.Link business opportunities and key differentiators from the Target Product Profile (TPP) to core labeling. Develop and maintain target eCCDS/CCDS, European labeling, and support US labeling development.Establish and maintaining core labellingAct as an expert in RA processes, RA due diligence, and RA clinical matters
Qualifications
To be successful in this role, we are looking for a candidate with the following qualifications:Preferred Master of Science (life sciences) relevant experience and/or PhD with 9+ years of relevant regulatory experienceThorough understanding of regulatory science and requirements across various regions including EU, US, China, Japan, and others.Experience in life cycle management, label development, health authority interactions, and device development.Proficiency in regulatory intelligence and therapeutic area knowledge.Demonstrated project management skills.Understanding of business management and the R&D value chain in the pharmaceutical industry.Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology.Knowledge of patient access, real-world evidence, and proficiency in written and spoken English.
Deadline
Apply on or before: 10th May 2024
