Måløv

Regulatory
Måløv

We are looking for an engaged regulatory affairs specialist to join the Stem Cell Development team in the Novo Nordisk Stem Cell R&D unit. If you are curious about drug development within cell therapy, willing to take on leadership and be an ATMP regulatory affairs expert in a team-oriented “biotech-like” working environment within a larger pharmaceutical company, this could be an exciting opportunity for you.

About the department

Stem Cell R&D is a Transformational Research Units (TRU) created in the fall of 2018. We aim to cover the whole R&D value chain within stem cell-based therapies, from research to product approval. The Stem Cell Development VP area includes non-clinical, clinical development and regulatory affairs and our drug development approach is to a large extent built on collaborations and partnerships.

The position

You will be the regulatory affairs specialist for assigned projects in the Stem Cell R&D portfolio and consult on regulatory matters within our unit. As a leader of regulatory teams and member of global project teams you will play an active role in creating and implementing our drug development strategies and plans.

We expect you to be a dedicated team player and find it easy to build working relationships with proactiveness and integrity. You will report to the VP of Stem Cell Development in Stem Cell R&D. The position is based in Måløv, Denmark and international travelling is part of the job.

The Regulatory Affairs Director position includes the following general responsibilities:

Develop and implement regulatory strategies for Stem Cell R&D projects
Represent the regulatory function on cross-functional drug development teams
Plan, prepare and manage submissions to regulatory authorities including FDA, EMA, PMDA and other national authorities
Prepare meeting requests and briefing documents, and coordinate and prepare teams for meetings with regulatory authorities
Keep up to date with Advanced Therapy Medicinal Product (ATMP) regulatory requirements, guidelines and legislation and train Stem Cell R&D staff in relevant regulatory matters

Qualifications

You should, as a minimum, hold an academic degree in life sciences. Additional desired skills and competencies include:

10+ years of regulatory affairs experience in the pharmaceutical industry, including CMC, non-clinical, clinical and drug/device combination development
In-depth knowledge of regulations, guidance, policies and procedures in drug and biologics development; experience in developing cell or gene therapies desired
Experience in providing strategic advice and executing global regulatory strategies
Experience with preparing INDs/CTAs and other regulatory submissions
Experience of interacting with key regulatory authorities e.g. FDA, EMA, PMDA
Broad understanding of global drug development
Excellent analytical skills and innovative ways to solve problems
Advanced level written and spoken English

Contact

For more information, please contact Niklas Öhrner at +4530792512

Deadline

31 July 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 chronical 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Måløv.

Jobbet er oprettet på vores service den 10.6.2020, men kan have været deaktiveret og genaktiveret igen.

Rapportér

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

Type: Apoteker
Sted: Måløv
Ansøgningsfrist: Fredag den 31. juli 2020

Rapportér

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