CMC Regulatory Leader - US & LatAm - Biologicals - Raleigh, North Carolina (code USA 170120)

Reference: MG170120

Expiry Date: 17-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Durham County
United States

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Job Description

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 Team

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.

The Role

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.

Experience Required

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

  • Direct US BLA Or PAS, CBEs or international Variations experience for DS and DP
  • Have managed US plus 1 other region (ideally LatAm) in a Regulatory CMC Liaison role
  • Have worked with CMC sub teams on major DS and DP changes for either recombinants, plasmids or mAbs
  • Any Spanish language skills would be useful (advantageous but not a pre-requisite)
  • Be willing and able to work in Boston, Cambridge or Raleigh / Durham, North Carolina


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 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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