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Senior Regulatory Professional in RA CMC Biopharm - Denmark  

Company managed [?] Still accepting applications

Posted on : 20 March 2017

Project Description


Job Description
  • Join a fast-changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and market authorizations worldwide for all company medicinal products across the globe. 
  • The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. 
  • This makes RA a truly interesting place to work – but also quite challenging. 
  • Are you up for this challenge in the near future?


About the department
  • The department “RA Chemistry, Manufacturing and Control (CMC) Biopharm 2” is part of RA CMC Biopharm in Regulatory Affairs and is situated in the company project house together with other regulatory affairs functions. 
  • We are a group of 12 highly skilled and dedicated people involved in every CMC aspect concerning marketed products as well as projects in development within Hemophilia and Growth Hormone disorders. 
  • The project portfolio is developing and in order to be able to handle the tasks and challenges within our area of responsibility we are looking for one more colleagues for the department.
  • You will work with experienced and engaged colleagues and work closely with many different stakeholders within company headquarters and affiliates. 
  • In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for CMC submissions and is responsible for interactions with regulatory authorities.



The position
  • As Senior Regulatory Professional in RA CMC Biopharm 2, you will be involved in a variety of regulatory tasks ensuring fast approval of our Clinical Trial Application (CTA’s), marketing authorization applications and variation applications in Life cycle Management (LCM). 
  • This means that you will compile, submit and maintain applications for our product portfolio.
  •  You will be expected to provide regulatory CMC input, be proactive, challenge the discussions and contribute to project team decisions, ensuring high quality CMC input to the regulatory strategies and submissions.
  • In addition, you will plan, coordinate and review regulatory documentation, chair internal working groups and be our primary RA point of contact for the Production and Product Support units in our company.



Qualifications
  • You hold a scientific Master’s degree within Chemistry, Pharmacy, Engineering or similar, and you have at least 3-5 years of regulatory experience combined with solid analytical Chemistry, drug substance or drug product knowledge from the pharmaceutical industry or a medicinal agency. 
  • Furthermore, you have experience with either CTA applications, marketing authorization applications or variation applications.
  •  On a personal level, you demonstrate that you are organised, detail-oriented, a proactive problem solver and you enjoy working in a team and project oriented organisation. 
  • You communicate well and are completely comfortable speaking and writing in English and preferably also in Danish.
  •  In addition, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. 
  • You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.



Working with Us:
  • We strive for excellence. 
  • As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, 
  • We offer our employees opportunities for continuous growth.