- Regulatory Affairs
- Denmark - Søborg
Do you want to be part of setting the regulatory scene for future diabetes products? Do you have strong collaboration skills, a strategic mind-set and experience with solid oral dosage formulations? If so, we are offering you the opportunity to be part of a strong performing team working with regulatory CMC for an innovative tablet product currently in development.
About the department
The RA CMC GLP-1 & Obesity department is responsible for the regulatory CMC activities within the GLP-1 & Obesity project portfolio of Novo Nordisk A/S. The department is divided in two teams: Liraglutide & Early Projects and Semaglutide Projects. The open position as RA CMC expert is in the latter team. The team is situated in the Novo Nordisk project house alongside other regulatory affairs units in Søborg. We are a team of 6 highly skilled and dedicated people involved in every regulatory CMC aspect concerning the semaglutide projects. We work closely with stakeholders within Novo Nordisk headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities around the world.
The job
As a regulatory CMC expert, you will be responsible for providing regulatory input and advice in the cross functional oral semaglutide project and to provide CMC input to global regulatory strategies and submissions. You will be the primary responsible person for all regulatory CMC aspects concerning the drug product oral semaglutide. You will plan, coordinate, and review regulatory documentation, and be our primary RA point of contact for our stakeholders in the Production and Product Support units of Novo Nordisk. You will be responsible for interactions with regulatory authorities and will work closely with the Regulatory Project Manager.
As a regulatory expert you will evaluate proposed product modifications for global regulatory impact and complete regulatory assessments as needed. You will also ensure compliance with regulatory agency regulations and interpretations.
Qualifications
You have a Master degree or Ph.D. within science e.g. pharmaceutics, biomedicine, chemical engineer or a related field. We expect you to have at least 5 years of regulatory experience within the pharmaceutical industry working with regulatory aspects of CMC. It is advantageous if you have an in depth knowledge and experience with solid oral dosage forms and/or peptides.
You have a strong scientific understanding and have successfully worked in project teams. You communicate well and are fluent in speaking and writing in English. On a personal level, you are a team player and thrive in busy and changing environment and carry a can-do attitude. You keep focus on meeting the project targets and timelines, work independently and find new solutions to reach the goals.
At Novo Nordisk your skills, commitment and ambition will help us change lives for the better. In exchange, we offer you a chance to work with highly skilled and dedicated people and to develop professionally and personally.
Contact
For further information, please call Sabine Tarp +45 3075 5404 or Nicolai Listov-Saabye +45 3075 4135.
Deadline
25 January 2016.
