Global Regulatory Lead to Regulatory Affairs
Novo Nordisk Regulatory Affairs (RA) 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 Novo Nordisk’s advocates around the world and make a meaningful difference to our business.
About the department
The RA Chemistry, Manufacturing and Control (CMC) Human and Modern Insulin department is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of 14 highly skilled and dedicated people involved in every CMC aspect of the regulatory files and licenses. The CMC Human and Modern Insulin department is responsible for life cycle management of the marketing authorisations for the Novo Nordisk marketed human and modern insulin product portfolio and we provide regulatory input to the throughout the entire life cycle management of the product portfolios.
We work closely together with stakeholders within Novo Nordisk headquarter, our multiple global manufacturing sites, our affiliated offices and health authorities around the world. A key stakeholder is the Supply Chain Organisation responsible for a global supply strategy for the diabetes market. We support the supply strategy by ensuring worldwide approval of the manufacturing sites at the health authorities around the world.
The department is working closely with the global manufacturing sites as well as our affiliated offices in making regulatory documents and dossiers of high quality for global submissions. This includes being responsible for maintaining regulatory compliance for our dossiers by providing assessment of the regulatory impact of changes made to the production of the Diabetes products. When relevant these changes are reported to health authorities globally.
As a Global Regulatory Lead, you will be responsible for the contact to our key stakeholder in the Supply Chain organisation, and you will represent regulatory affairs in the cross functional project organisation and provide regulatory input to support the supply strategy.
You will be identifying trends in the global regulatory environment and utilising the gained knowledge in order to customise high quality dossiers for obtaining regulatory approvals. You will be responsible for coordinating submission planning in collaboration with the RA submission responsible and stakeholders in the manufacturing plants and the affiliated offices.
You will use your regulatory insight to facilitate on how to gain fast track approval. This is to accommodate the increasing supply demands, maintaining a competitive manufacturing cost and secureness of global product availability.
On a daily basis, you will also follow up with the regional and affiliated offices to ensure the advancement of upcoming and on-going submission & approval activities. You will support the affiliate offices in responding to requests from authorities and reviewing the documentation needed for submission.
Finally, you will be the RA CMC direct responsible individual for the global drug product manufacturing sites securing fast and comprehensive support. You will be responsible for supporting critical and urgent incidents related to the supply and manufacturing flow identifying root cause and sustainable solutions.
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 humour is always welcome.
Travelling should be expected including both to global manufacturing sites and to affiliate offices.
You have a university degree in science. You have at least five years of documented professional experience from a regulatory affairs position in the pharma industry.
You are an experienced Project Manager with proved track records in executing complex projects within tight timelines. You have experience interacting directly with regulatory authorities on an international scale and have excellent people collaboration and communication skills and successfully drive your projects across geographical, cultural and organisational borders. Furthermore, you work independently for the success of your projects, but do it with respect for portfolio priorities. Experience with supply chain organisation is preferred but not mandatory for filling out the position.
As a person you apply an innovative approach and never lose strategic focus. You are result oriented, well-organised with a natural drive. You act as a role model by maintaining your drive and optimism even under pressure. You are fluent in speaking and writing in English.
Working at Novo Nordisk
At Novo Nordisk, 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.
For further information, please call Jacob Larsen at +45 3079 1441 or Jens Bjørn Nielsen at +45 3075 6120.
18 February 2018.