Senior Regulatory Affairs CMC Professional

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

 

Do you have experience as Regulatory Affairs (RA) Professional in Chemistry, Manufacturing and Controls (CMC)? Are you able to lead and develop regulatory strategies for high-impact initiatives, and do you want to collaborate with decision-makers and experts across multiple functions in a global environment? If yes, we are looking for you!

 

The Position

 

As a Senior RA CMC professional in our area, you will be part of a fantastic diverse team of 15 people. We set regulatory strategic direction for the monoclonal antibodies in our pipeline – covering early to late stages, such as CTAs, submissions and roll out worldwide. 

 

The strategies are developed side-by-side the maturation of the CMC activities and your first task will be to help managing and driving submissions of a new product worldwide together with the project group.

 

You will also:

 

  • Encourage submission planning, applying intelligence and developing global regulatory strategies
  • Guide preparation of regulatory CMC file together with authors and stakeholders in our CMC Development and Product Supply organisations
  • Drive submission of regulatory files, response to questions from health authorities and maintenance of marketing authorisation globally
  • Support communication of approval and archiving
  • Drive the planning and conduct of regulatory authority interactions

 

You enjoy working in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. The atmosphere is informal and good humour is always welcome.

 

The position will be based in either our headquarters in Søborg, Denmark – or for applicants currently based in the UK, in our UK affiliate in Gatwick, UK.

 

Qualifications

 

  • M.Sc.or Ph.D. in Biochemistry, Pharmaceutical science, Chemical engineering or a similar university degree
  • +5 years of relevant experience in pharmaceutical industry
  • +3 years of experience in regulatory CMC will be a plus
  • You have a strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations (manufacturing, process development, analytics, and quality assurance)

 

You are a curious person with eager to learn, well organised and proactive. You enjoy working in a diverse and global team and in a project-oriented organisation. You can also work independently and bring an innovative mindset seeking novel solutions to the challenges we face, with a healthy sense of humour.

 

You are high proficiency in English, in order to communicate topics related to CMC of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities.

 

About the Department

 

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets. In RA CMC Biotech & Rare diseases we are a group of 35 highly skilled and dedicated people divided into three departments and involved in every regulatory CMC aspect concerning marketed products as well as our growing pipeline covering small molecules, monoclonal antibodies, Advanced Therapy Medicinal Products (ATMP’s) as well as cell and gene therapy.

 

Working at Novo Nordisk

 

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

 

Contact

 

For further information please contact Dorte Lunøe + 45 30 79 02 17.

 

Deadline

 

Apply before 14 August 2022.

 

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.