Expiry Date: 25-05-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
REGULATORY GRL - have US NDAs/ s/NDAs? Want to move up to a GRL role? Raleigh, Durham/ RTP/North Carolina
My client is seeking an individual who has at the very least, a good understanding of global drug development and registration (through involvement in project teams) and who now feels it is right to step up to a global regulatory leader role!
You will take over a submission preparation team, pre-submission, and take another indication through global filing, in a company where the GRL role sits with commercial, and supports directly the commercial and development leads.
The company has a strong pipeline, is led by experienced and well-known individuals who have a pedigree for development of their people and regulatory teams, that said, you will spend most of your time directly with the commercialization folks, and with your regulatory sub-teams.
The role is for someone who is able to manage the expectations of commercial and development partners while identifying opportunities with the business to bring both new markets and new indications to patients more quickly. After working on this high profile product, you will transition to a new NBE or recently registered product to work on a new set of life-cycle strategies (those with clinical studies dependant).
I would readily want to hear from you if you have relevant filing and approvals experience in the US with / without international, and think this is the right step for your career.
You want to work on a Blockbuster to lead its final 2 clinical indications / label extensions before moving to another NME or new product:
To apply for this role, please contact Theo on US 908-348-6714 or Roland on 908-348-6717 or press the red “Apply for position” button or send us an email to email@example.com and we will reply by return. We will support you throughout the interview and on-boarding experience.
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