Expiry Date: 20-12-2021
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs Global CMC Leader - FDA, Europe, AsiaPac & LatAm - Based in Boston, Cambridge, MA
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 NDA/MAA 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 Global 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 a product in Phase 3 development, and then drive the teams in matrix to deliver the initial submissions in 25 major markets
We want someone who has both FDA and/or EU experience, who wants to also manage other international and core markets (including Japan) through your matrix reports and regional liaisons. This is 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 hit the Apply button or contact Theo Moore on US toll free 855.505.1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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