Regulatory Affairs Director - Cell Therapy

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Måløv

We are looking for an engaged Regulatory Affairs Director, ideally with cell therapy experience, to join the Cell Therapy Development team in the Novo Nordisk Cell Therapy R&D unit. If you are passionate about developing potentially curative therapies for serious chronic diseases like diabetes and able to take on leadership and be an Advanced Therapy Medicinal Product (ATMP) regulatory expert in a team-oriented “biotech-like” working environment within a larger pharmaceutical company, this could be an exciting opportunity for you. The position You will be the Regulatory Affairs Director for assigned projects in the Cell Therapy R&D portfolio. The position involves leading the regulatory team as well as being the nonclinical and clinical regulatory expert. Given the nature of our products there is a strong focus on CMC and cell delivery and as Regulatory project leader you will be involved in those discussions as well. You are expected to create and ensure implementation of the regulatory strategies in assigned Global project teams as well as contribute to the overall Cell Therapy Development strategies and plans, as projects advance from research, CMC and device development into clinical trials. In this role, you will contribute to the success of Cell Therapy Development and Cell Therapy R&D by:

Having an in-depth knowledge of ATMP (particular cell therapies) and combination product regulatory requirements.

Having extensive global regulatory experience with CTAs/INDs and in obtaining marketing authorisation in the EU, US, and other major countries.

Being able to generate global regulatory strategies.

Compiling, reviewing, and submitting pre-meeting packages for health authority meetings, conducting rehearsals, participating in meetings and ensuring timely, complete, and high-quality answers to health authority questions.

Providing guidance to secure adherence to ATMP and device/combination product regulatory requirements.

The role requires the ability to work effectively with people from different functions and organisational levels, across diverse geographies, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders. You will report to the Head of Cell Therapy Development in Cell Therapy R&D. The position may be based in Måløv, Denmark or in Fremont, CA, USA. Qualifications You should hold a life science academic degree and ideally have 10+ years of relevant experience within regulatory affairs. Additional desired skills and competencies include:

In-depth knowledge of ATMP (particularly cell therapies) and combination product regulatory requirements.

Extensive global regulatory experience with CTAs/INDs and in obtaining marketing authorisation in the EU, US and other major countries.

Generate global regulatory strategies.

Ensuring compilation, review, and submission of pre-meeting packages for health authority meetings, conducting rehearsals, participating in meetings and ensuring timely, complete, and high-quality answers to health authority questions.

Providing guidance to secure adherence to ATMP and device/combination product regulatory requirements.

As all work takes place in multidisciplinary project groups, we expect you to be a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. About the department Cell Therapy R&D is a Transformational Research Unit within the Novo Nordisk Research & Early Development EVP area. We are more than 260 employees and cover the whole cell therapy R&D value chain, from research to product approval. Our current portfolio includes projects for treatment of type 1 diabetes, Parkinson’s disease and chronic heart failure. Working at Novo Nordisk At Novo Nordisk we recognise 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 the communities we operate in. Contact For further information, please contact Senior Regulatory Project Manager Anja Dahl Østergreen at +45 30798007. Deadline 1 August 2023 Please note that applications will be assessed on an ongoing basis and therefore the advert may close before the recruitment process is completed if we have proceeded with candidates to the screening or interview phase. 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.

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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Måløv.

Jobbet er oprettet på vores service den 8.6.2023, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.

Type: Øvrige
Sted: Måløv

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