Expiry Date: 30-08-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory Director - Strategic Label Input on NMEs (MAAs/LEs/CCDS/TPPs)
Note: This role is based in Mainland Europe and comes with a great relocation package for certain nationalities including private schooling, relocation and a tax reduction package, as well as an exciting stock plan, plus full assistance for relocation (temporary apartment, disturbance allowance, logistics and support). UK candidates will be supported after Brexit to gain valid visas which is not a difficult process in this location and country.
About the Company
This is a growing biopharma which is going through an expansion phase, has recently acquired a company, and had 5 NMEs in registration studies right now. It’s a medium-sized organization, and is very focused on delivering speciality medicines to their patients. The leadership team in regulatory is well-known, has a strong stable track record, and is supportive of their staff.
About the Role
The role is focused on leading a global workstream (although you might only have EU plus some Emerging markets, this is OK as long as you have managed / led new CCDS / major CCDS updates and have inputted on to draft strategic labels) – as well as the management and development of your team, the stakeholder network, bringing more vigour and rigour to the dialogue with commercial and the Global Regulatory Leads on draft labelling and TPP, as well as directly and through your team, getting the labelling ready for new product launches and new line extensions (clinical indications, label expansions, paediatrics, orphan).
Skills & Experience
So I am seeking an labelling professional who has managed 3-5 label leads before and wants to step up into a global regulatory labelling position, as a Director for this company based in mainland Europe. You will have already worked in labelling and have a track record in regulatory labelling.
You will lead a small group which is focused on strategic labelling, and management of CCDS (there is another team which does to pack and labelling ops) which my recruitment firm has had a part in hiring. The role work in a hands-on role (you will have your own project / product), plus management and development of the team which is made up of Associate Directors and Senior Managers.
You will evolve the existing processes and systems, and work to provide further integration with the network and global teams.
Package & Benefits
The role comes with a Director grade salary, plus good bonus, stock which is RSU-based, as well as a company car with private / company use petrol card. There is full medical and insurances cover, and as mentioned, the role comes with a ‘red carpet’ relocation package!
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