Senior Consultant - Global Regulatory Affairs

Are you an experienced specialist in regulatory affairs within drug development on a global level? Become a part of NDA’s growing, highly qualified team!
Over the last years, NDA supported over 40% of the new medicinal products that were approved in the EU. The NDA headquarter is located in Sweden, Upplands Väsby, in-between Stockholm and Uppsala. We are now expanding our consultancy business with a Senior Consultant located in Sweden or in Denmark. The position is permanent, open-ended and full-time, starting upon agreement.
Responsibilities
As a Senior Consultant at NDA you provide our clients with strategic and operational support concerning regulatory affairs within drug development on a global, national or regional level. You manage and take part in complex and challenging projects from international companies or local start-ups within different therapeutic areas.
Qualifications
In-depth experience of regulatory strategies on a senior advisory level
Vast knowledge of regulatory affairs within drug development in different countries and regions (e.g. Europe and US)
Experience from pharmaceutical industry and/or medical agencies.
Experience from complex project management roles or equivalent and /or writing regulatory documents for e.g. clinical trial applications and marketing authorisation applications for EU and USA, orphan drug designation applications (ODD), Paediatric Investigation Plans (PIP), Scientific Advice procedures etc.
Academic degree within life science.
Expertise within clinical development and/or experience working with Advanced Therapy Medicinal Products (ATMP), is desirable.
Excellent spoken and written English.

You are proactive, collaborative, adaptable and confident in decision-making. You enjoy networking and actively contribute to business expansion.
About NDA
NDA is Europe’s leading regulatory drug development, pharmacovigilance, HTA and scientific communication consultancy with offices in Europe and the USA.
We support life science companies all over the world and across all phases of development, from pre-clinical to post marketing, to the needs and requirements of regulators and payers alike. We work together with our clients to address key strategic regulatory and reimbursement challenges. Our scientific expertise covers all major therapeutic areas.
NDA has about 150 employees with industry and regulatory agency backgrounds, supported by a network of over 1 000 scientific, clinical, regulatory and drug development experts.
Application & Contact
For more information about the position, contact Robert Kronqvist, General Manager or Anna Leitgeb, one of our consultants. For Danish applicants you may also contact Katja Gustafsson, a consultant based in Denmark. Please call our switch board +46(0)8 590 778 00.
Send your application (CV and letter) to Recruitment@ndareg.com
Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible. 
Last application date: 21 February 2020.