Expiry Date: 17-08-2020
Category Regulatory Affairs
Job Type: Full Time
CMC Regulatory Leader - US & LatAm - Biologicals - Raleigh, North Carolina
Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
My client is one of the industry’s best success stories in the bio-/pharmaceutical sector, and have doubled their R&D spend and revenue pretty much consistently every 5-7 years since I have first worked with them 15 years ago. This is one organization which can offer individuals with a ‘can do’ and ‘let’s make it happen’ approach, a match in terms of culture and working style.
The Regulatory CMC team, works directly with Process Development, Analytics, Technical Services and mfg and supply chain to ensure IMP development and first BLA filings are supported, and then for lifecycle, to manage DS and DP changes, new market entry and new injectors are delivered to the patient and markets in a timely manner.
This role is for CMC RA strategy, liaison and delivery role (as a matrix leader for local RA CMC Sr Managers around the world), as you will devise and implement the overall strategies for 2 well-known marketed products, and then drive the teams in matrix to deliver the submissions.
We want someone who has both FDA and LatAm experience, who wants to also manage other international and core markets (EMA and AP) through your matrix reports and regional liaisons. It will develop into a global role.
You will have the following experiences to be eligible for this role:-
In return, my client is willing to pay competitive (better than most) packages, including a high performing stock plan with decent vesting timelines, performance bonus and decent medical / insurances and extra-legal benefits.
For compelling candidates a relocation package is available.
To apply for this role, please press the red “Apply for position”, or contact Matt or Theo on 855.505.1382. We wish you a successful 2020 and fortuitous year!
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