Expiry Date: 30-06-2023
Category Regulatory Affairs
Job Type: Full Time
About My Client
My client is a real trooper, has a defined way of collaborating, a filing track record you can learn from and brings the amount of knowledge in rare diseases few in North America have to offer a direct report. They are in themselves a rare individual. This individual is superb at helping Regulatory staff fill in and consolidate their knowledge without stepping on their toes. You will work as a Senior GRL on EU and US based programs for Rare Disease, for 2 NMEs in parallel, to bring these NMEs from Ph 1b and 2a into pivotal study. The modality or molecule type is disease modifying and also novel.
About The Role as a Senor Regulatory Director & Strategist
You will have strong US regulatory experience plus knowledge of the EU regulatory framework and be happy working in early development for the next couple of years (the NMEs will go to late stage data pending, around the end of this timeframe).
You will enjoy working with the science not just the regulations, in a company where many of the senior executives are also working on the Global Project Teams, and you will be pleased to know, although this is not related to the role but shows they have invested, the drug manufacturing is in-house and they have a supportive CMC person within QA and Mfg.
You will have ownership for shaping and developing regulatory strategies to take advantage of new data, in a company where the LT is very regulatory aware and have a successful track record in developing and commercializing well-known brands for medium and large pharmaceutical companies.
You will have worked either in rare diseases, this could be any spectrum of indication types, and ideally have some knowledge of any RNA type molecule or similar cell or gene therapy of Oligos.
You will be someone who is reliable, dependable and engaging, however, someone who also can give advice and change the consensus based on smart strategies and quantifiable risk-taking by working with the stakeholders to advocate on your strategies (you will find they encourage this).
Location & Package
My client will allow fully remote working for any individual in the East Coast to Central Time or Midwest. Additionally, you will be encouraged to spend some days a month on site (during peaks), not because of dictate but because they think it is important to spend time with each other, attend global project meetings or plan for FDA or EMA regulatory meetings.
The package is commensurate with the grade, and comes with both annual and joining stock / stock options, as well as a decent performance bonus. The salary rate is in the mid to upper 200Ks as you can imagine depending upon your level of capability and if you have been a Senior Director already.
In the first instance, please contact me, Theo Moore or my colleague, Ivan Nash on US +1.587.216.9302 or +1.908.378.8980 or send a full CV to me, Theo@AdvTalent.com and I will reply by return. I am based on West Coast so happy to take calls in the early evening Eastern standard.
ADV Talent will help you each step of the way and know the stakeholders and line manager well and help you show you how to display your capabilities and strengths beneficially