Join Our Team
Are you experienced in regulatory affairs on a global or local level?
Role
Consultant Regulatory Affairs
Responsibilities
As a Consultant at NDA you will provide our clients with operational and strategic regulatory support on a global, national or regional level. The work may include application for Orphan Drug Designation, Marketing Authorisation and Variations.
You will provide Regulatory advice on a general or local level and have continuous interactions with regulatory bodies. The work as consultant is very varied and you will have great opportunity to develop professionally.
Qualifications
- At least 3-5 years of experience from the pharmaceutical industry and/or regulatory agencies.
- Experience from project management roles or equivalent for e.g. clinical trial applications, variation applications and marketing authorisation applications for EU and/or USA, orphan drug designation applications (ODD), Paediatric Investigation Plans (PIP), Scientific Advice procedures etc.
- Experience from pre-clinical/clinical development is desirable.
- Academic degree within life science.
- Excellent spoken and written English.
As a person you are proactive, collaborative, adaptable and confident in decision-making. You enjoy networking and contribute actively to business expansion.
Become a part of NDA’s growing, highly qualified team!
Application & Contact
For more information about the position, contact Maria Nilsson Hagberg, Consultant Manager +46 72 384 31 37
Send your application (CV and letter) to Recruitment@ndareg.com
Selection of candidates & interviews will be conducted continuously so please submit your application as soon as possible.
Contact us
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
Let's Bring Medicines to the World