Regulatory Affairs Product Lead
- Contract Type
£800.00 per day
Based in Stockholm, Sweden
This industry leading Biopharmaceutical company have made headlines around the world with not just their product line and phenomenal portfolio, but also their fantastic business acumen and the strategies for growth which they have undertaken over the past few years.
As part of this strategy for growth, this company are looking for new contractors to help with their expansion plans and existing products whilst they go through and exiting new transition period.
One such position is that of the Regulatory Affairs Product Lead covering all of the Nordic regions.
Working at a management level, you will have oversight for products within this company’s portfolio. Products specifically relating to Immunology and Haematology are the ones being focussed on for this role.
The main function of your role will be providing Regulatory Strategy and support for the company portfolio based out of the Nordic area. Your responsibilities for these products are all encompassing including checking the labelling and working on variations as required.
You will have to:-
- Liaise with National Regulatory Authorities for the EU and Nordic areas
- Conduct Clinical Trial Applications (submission of PASS protocols etc) if applicable
- Attend and facilitate Scientific Advice Meetings
- Conduct business support duties (Launch commercial teams for assigned product franchises, product support for tender and pricing applications)
- Have interactions with PV (working closely with their department)
- Proactively monitor national regulatory landscapes (regulatory intelligence)
- Product labelling responsibilities
To be considered for this role you will need:
- Have a Batchelors or Master’s Degree in a scientific discipline
- Have a minimum of 8 years’ experience in a global company within a regulatory function
- Have proven experience and relationship with Nordics Regulatory Authorities.