Expiry Date: 28-09-2021
Category Regulatory Affairs
Job Type: Full Time
Associate Regulatory Director ** Remote ** MidWest or East Coast ** Self-motivated, self-propelling US Liaison role **
About My Role
My client has hired many individuals from us this Summer, during Covid, and they have assigned a new role to work in the rare diseases space (still, after ODD, they will still have full Ph 3 registration studies for a number of indications), to jump in on a new indication or two, and run as the US Liaison in a team of 4 Liaisons and Scientists.
We are looking for a self-propelling individual who has the personality to work from home in the long-term, this does not mean you will not visit site, but the company has MS Team and a digital hiring process in place, and the regulatory function is now used to working remotely. Is this you?
You will be responsible for managing a Ph 3 program as the regulatory lead plus preparing other new indications or extensions from Ph 2A onwards, the EOP2 / Pre-NDA meetings, working with the clinicians, GRL, PL, and sub-teams, for your assigned program.
Personality-wise, you will feel as happy on a video screen as you would on a face to face meeting, know how to manage your time, and have the requisite regulatory experience to provide input, tactical and strategic guidance, and possibly in time grow into a GRL, in your own right, this option is open to you.
In terms of hard skills, you will have already worked on providing regulatory project management and regulatory input into Ph 2/3 designs, FDA meetings, and have co-/led or assisted on a major filing at NDA or sNDA or BLA or sBLA milestones, or have managed a rollout of Supplemental filings you inherited at the very least! If you have worked at a CRO doing actual consultancy or an R&D-based Pharmaceutical Company, small or large, then we would like to hear from you!
The Package & Hiring Process
In return, my client will let you work remotely, and provide a significant package including a stock plan, high achieving performance bonus, decent salary, plus health etc. The company will buyout a certain level of stock and performance bonus loss for the right individual! If you change your mind about location much later on, there is a ‘Cadillac’ relocation package on offer if needed.
ADV Talent know the line manager incredibly well, and will prepare you for the process (which is not a long one) based on your real life career achievements. You will be interviewed and on-boarded digitally!
In the first instance, either please send a full CV to CV@AdvTalent.com or call us, asking for Theo on 855-505-1382 or for late PMs and weekends (AMs only), please call Matt on 908-332-9157 - all applications are in private, and as this role offers remote, we expect it to go quite quickly! Alternatively, please press the red “Apply for position” button and follow the registration process.
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