Regulatory Professional in CMC Human and Modern Insulin - Denmark
- Our company makes medicine available to patients all over the world by ensuring rapid regulatory approval in all of our markets.
- Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as company’s advocates around the world and make a meaningful difference to our business.
About the department
- We are a group of 15 highly skilled and dedicated people involved in every CMC aspect concerning the regulatory files and licenses, as well as providing regulatory input during the various phases of drug development.
- We work very closely with stakeholders within company headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities around the world.
- The CMC Human and Modern Insulin department is responsible for life cycle management of the marketing authorizations of our company marketed human and modern insulin products as well as new products within the therapeutic area.
- The department is responsible for maintaining regulatory compliance by providing assessment of the regulatory impact of changes made in the manufacturing sites to the production of the insulin products, and as relevant negotiate and report these changes to health authorities globally.
- The team is working closely with the manufacturing sites as well as our affiliate offices in making regulatory documents and dossiers of high quality for global submissions.
- As a regulatory professional, you are responsible for planning, coordinating and submitting variation applications and to provide regulatory input in the cross functional projects you are involved in. On a daily basis, you will support affiliate offices in responding to requests from authorities and reviewing the documentation needed for submission.
- You will review and assess change requests and non-conformities and play an important role in ensuring work processes are working smoothly and optimally.
- You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication.
- The atmosphere is informal and good humor is always welcome.
- You have a University degree in Science and documented professional experience from a regulatory affairs position and/or the Pharma industry.
- You are organised, a good planner and exhibit driver.
- You show a winning attitude and keep your spirits high even when under pressure.
- You are a strong team player and can also work independently.
- You are fluent in speaking and writing in English.
Working with Us:
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.