** Regulatory Affairs Global CMC Manager / Sr Manager ** X-Train to Gene Therapies – Boston, MA or Remote / Home-Based

Reference: TM311021AR1

Expiry Date: 30-06-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

About this Gene Therapy RA CMC Opportunity:

  • This company is smaller but has already achieved with their first product, Marketing Authorization
  • This is one of those rare opportunities for someone who has a PhD or Masters relevant to ATMPs, and now in Regulatory CMC to switch from mAbs to recombinants to Gene Therapy products and work on ATMPs
  • The role can be Boston MA based or fully remote!
  • Experienced team head will train you on the differences in modalities and you will immediately work on ATMPs in Ph 2/3 and support final BLA builds
  • Global team, but your US experience is what we are looking for, or you will have worked on core dossier M3s

You will be mentored and coached to take on projects as a RA CMC Lead for a number of ATMP’s  for a very highly-rated growing Gene Therapy Biotechnology company that provides great training and access into Gene Therapy products!

This is a great newly created role with to support a strong pipeline (more than a dozen targets sharing each with a distinct indication and using a common technology platform) of early, mid and late stage NMEs with 2 new registrations planned in the for 2022/3

The leadership team are well established and they have excellent reputations within the industry, and a number of high profile regulatory submissions as achievements.

Your Role 

This will be a varied and broad-based role, where there are opportunities to be involved at each stage of the development process and/or supporting  the upcoming MAA/BLA’s  for a number of products. After induction and training, you will operate as the Regulatory CMC Liaison for your projects, reviewing and building submissions, developing effective proactive CMC strategies in global role supporting  products in both the US and EU.

In return my client is seeking professionals who can influence stakeholders, is mindful of cross-cultural differences and understands the regulatory framework.  Ideally you will be a collaborative team player with excellent planning, organizational and project management skills who is proactive and flexible in attitude and approach and must be able to demonstrate excellent communication and relationship-building skills.

A decent package is on offer and my client will consider for the right person buying out stock or bonus losses.   

It’s essential to have Regulatory CMC experience in Biologicals, for development but full training will be provided into Gene Therapy products.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to theo@advtalent.com or if you would like more information on the role, on US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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