Science-driven Regulatory CMC Expert for innovative development projects
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Søborg
- Regulatory
- Søborg
Are you an ambitious and science driven regulatory CMC expert who wants to work with innovative investigational medicines for the treatment of rare blood disorders and rare endocrine disorders? Are you able to take the lead and drive regulatory strategies for high impact projects and would you like to work together with decision makers and experts across multiple functions in a global environment?
The position
As an expert profile in our department, you are expected to demonstrate leadership by setting regulatory strategic direction in high impact projects and in highly scientific settings. Strategies are developed in accordance with CMC development activities and it is necessary to be able to turn scientific progress into regulatory pathways.
In addition, you will be guiding younger colleagues as well as participating in cross functional expert panels.
Key responsibilities consist of:
- Being a part of development projects, you will e.g. plan, coordinate and review the regulatory documentation in submission packages, responses to agency questions for global markets as well as ensuring timely and efficient submissions of regulatory dossiers and plans to Health Authorities.
- Willingness to continue your individual development and stay updated within relevant regulatory and biotech disciplines.
- Maintaining your external networks to benchmark and bring up discussions with peers.
- Working in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures and circumstances.
Qualifications
What we expect from you:
- 10+ years of relevant experience from the pharmaceutical industry including min 6-8 years regulatory CMC experience either from the pharmaceutical industry or from a medical agency.
- A proven track record of working with ATMPs and/or Gene therapy as well as protein-based biologics is preferred.
- A strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytical, and quality assurance).
- Ability to communicate topics related to protein chemistry/analytical chemistry/manufacturing of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities.
- High proficiency in English.
On a personal level you are:
- Curious to learn, well organised and a proactive problem solver.
- Enjoying working in a team and in a project-oriented organisation.
- Thriving in an environment with changing circumstances and bring a can-do attitude and a healthy sense of humour.
- Focus on jointly moving the projects, can work independently and bring an innovative mindset seeking novel solutions to the challenges we face.
Education:
- M.Sc. and/or Ph.D. e.g. in Biochemistry, Pharmaceutical science, Chemistry or a similar university degree
About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. In RA CMC Biopharm we are a group of 24 highly skilled and dedicated people divided into two departments and involved in every CMC aspect concerning our Biopharm and Haemophilia products. The early project portfolio is rapidly evolving and therefore we are looking for a senior colleague specialised in regulatory CMC strategies for e.g. ATMP and cell therapy products as well as protein-based biologics.
Working at Novo Nordisk
At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally. You will also have a chance to learn more about our innovative nature of the products. This position is based in prestigious office location in the main headquarter, Søborg, Capital area of Denmark. Assuming responsibilities will be involved in global strategy.
Contact
For further information please contact Dorte Lunøe +45 3079 0217 or Nicolai Listov-Saabye +45 3075 4135
Deadline
Please apply for the position no later than Dec 15th, 2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 12.11.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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