...briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorization, working with affiliates to ensure alignment...
...industry? If so, we have the perfect role for you as a Regulatory Professional responsible for Vault RIM in our Regulatory Affairs department... ...Knowledge of the overall RA business proces...
...Regulatory Affairs Consultant.
~8 years' experience in handling life cycle management of approved drug products (small molecules) in various markets.
~ Good understanding of regulatory framew...
...ISO 14971 Risk management, IEC 60601-1 , and particular standards.
Knowledge of Preparing Technical Documents for Product Technical File Dossier and Technical file Dossier Submission to the Notified Bodies.
Ex...
...people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 d...
...invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining ...
...a challenging and rewarding career, read on and apply today for a life-changing opportunity.
The Position
As a Regulatory Specialist at Novo Nordisk, you will have the following responsibilities:
Regulat...
...In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
Establishes and approves scientif...
...is responsible for managing global publication plan(s), publications budget for the respective products, collaborating closely with medical affairs colleagues, global development, discovery, regulatory, and affiliat...
