Expiry Date: 07-11-2021
Category Regulatory Affairs
Job Type: Full Time
EU Regulatory Associate Director ** Lead 2 new indications in Onc / Hemo *** Stock & Car
Covid Note: My client will be moving to a new hybrid model, you will work in the office 50% of the time, the rest at home if you wish, and my client is able to provide a relocation within Switzerland or to Switzerland as you require.
About My Client
This is a Top 10 US R&D based bio-pharma not a Swiss one with several high value assets marketed, and a strong pipeline in late phase development. The organization is a peer to the main other Oncology powerhouses. The company have the type of culture that is compatible to people working in a smaller company (they offer a fair degree of autonomy) or a larger Swiss led global biopharma (as they also have a strong value chain and clear lines of operation). There are many aspects I like about my client, accountability with right levels of support, clean and easy to navigate governance, excellent funding for development programs and new lifecycle, but most of all, the LTIs and incentives match the company’s credo. The role comes with health insurance, and a car, as well as a decent stock plan, not normal benefits for Swiss pharma.
About The Role
The role is a typical EU Regulatory Liaison but may be with a bit of a difference, in this TA, the EU regulatory leads have a lot more voice in the global teams, and more accountability in their region. The levels of autonomy are quite refreshing, so you will lead 2 new indications / label expansions for oncology in the region, to potential approvals, and my client said the data is promising not challenging.
You will report to a polished and capable people person, who is known for being very collegiate and supportive with her team, knows when to support and when to defend, and has a easy to communicate with. The individual knows the organization well and can really support you during your on-boarding in opening up channels for strategy and for influencing the overall global programs.
Your Experience & Skills
You will have either supported or filed a first MAA or new indications in either solid tumor or haematology, perhaps in rare diseases, and now want to be an Associate Director with a clear line of development to the Director grade in time. You will have some experience in early development but this is not a necessity. You will have co-/led EMA meetings, and internally pre- / post-core submission teams. Experience in label negotiation or review processes would also be useful. You might be graded as a Senior Manager or Sr Program Manager and would like to see your package increase in value commensurate with your new accountabilities.
To apply for this role, please contact Matt Greig or Oli Dimitrov on +44.207.801.3386 or +44.207.801.3388, or apply for this role by pressing the red “Apply for position” button. Alternatively, please send a full CV to firstname.lastname@example.org and we will reply by return. We do take calls after hours ‘til 8.30 CET and Saturday / Sunday AMs by calling +447918679405.
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