Expiry Date: 14-11-2021
Category Regulatory Affairs
Job Type: Full Time
Regulatory Managers, Sr Managers & Associate Directors *** Remote initially then relocate to Durham, NC in 2021
My client is a growing biotech with an ever changing pipeline which is good because their recent discovery and research efforts mean these NMEs now will include rAAVs and other novel modalities, on top of the company having 5 late stage programs pending Ph 3 to readout over the next 2 or so years. This is truly a time to join a company which is evolving their pipeline which will mean there is a great deal of rich development opportunity for aspiring regulatory professionals, to cut their teeth in regulatory for clinical development, initial BLA/NDA and sNDAs as each NME mostly has multiple clinical new indications.
The Team Director and VPs are all pedigree. The line manager is a very friendly, engaging, fair and sensible manager, who has top marks from her team for evolving their skillsets, identifying stretch objectives which can be achieved, and mapping your aspirations in the long-term to the projects available. Mid to late lifecycle is managed by a separate team, this is a pure regulatory development environment.
You will be responsible and accountable for your own deliverables, and receive coaching and mentoring from both the Global Reg Leads and the line manager, knowing you also have experienced VPs (some ex FDA) to help and guide you. The US Liaison and Global RL positions are open and also part of the career ladder, but, and I share this thinking, my client believes in steady progress taking many small steps to develop successfully so these roles are open when appropriate to you.
The company offer a decent level of salary, decent bonus level, and until next year, the chance to work remotely, prior to any move to Durham, NC, as long as you are willing to work with MS Team, and visit the office Covid allowing. My client has a digital hiring process, so you can be interviewed, assessed, offered and on-boarded from home! This was the first of our clients to put digital hiring in place, and they responded in a double-quick fashion, something we found reassuring.
The package also includes a relocation offer, for buying and selling a house, or renting, as well as disturbance allowances, removal costs and expenses for making any move run smoothly. Durham as a location is both great for bringing up children, as well as working / living, and offers a relatively high standard of living for less cost than Tri-State area or Illinois. It’s also somewhat warmer!
To apply for this role, please press the red “Apply for position”, or contact me, Theo Moore on US toll free 855.505.1382.
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