Regulatory Affairs Global CMC Leader - FDA, Europe, AsiaPac & LatAm - Based in Boston, Cambridge, MA (code USA 200421)

Reference: TM200421

Expiry Date: 20-09-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

Regulatory Affairs Global CMC Leader - FDA, Europe, AsiaPac & LatAm - Based in Boston, Cambridge, MA

Organization

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 Team

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.

The Role

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!

Experience Required

You will have the following experiences to be eligible for this role:-

  • Direct US NDA/MAA Or PAS, CBEs or international Variations experience for DS and DP
  • Have managed US plus 1 other region (maybe LatAm or AsiaPac) in a Regulatory CMC Liaison role
  • Have worked with CMC sub teams on major DS and DP changes for either recombinants, plasmids or mAbs
  • Be willing and able to work in Boston, Cambridge or Raleigh / Durham, North Carolina.

Package

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!

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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