Expiry Date: 07-01-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
About this Gene Therapy RA CMC Opportunity:
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.
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 for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to firstname.lastname@example.org or if you would like more information on the role, on +44(0) 207 801 3384. I will support you throughout the interview and on-boarding experience.
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