Job Description

My team and I are assisting our client, who are a mid-sized global Bio/Pharma with a strong & established portfolio, in finding an Associate Director of RA CMC to focus on their recently approved Small Molecule meds portfolio for Global expansion/commercialisation projects, that will include EU, US and all major markets. If your past Regulatory CMC experience really stands out and you have worked on global commercialised products as the Regulatory CMC Lead, then you would be well suited for this role!

We are looking for a result focused and detail oriented regulatory CMC professional with experience of working in global pharmaceutical companies, with multiple manufacturing sites and regulatory authorities worldwide. You will have a strong background and understanding of FDA, ICH, and other regulatory CMC requirements through MAA/NDA, post-approval, and life cycle of the product and have the ability to effectively manage multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues at a global level.

Responsibilities

Your responsibilities would be defining and implementing Global regulatory CMC strategies and the planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on recently approved FDA products. You will actively identify and assess global regulatory risks for various small molecules and implement filing readiness strategies.

Another deliverable will be managing in matrix, Snr Managers to deliver your VARs and Updates, for controlled / sustained release line extensions (the company wants to use their clinical data to effect better dosing through line extensions and this is a big franchise, multi-billion USD in terms of size). The team is around a dozen people and led by a successful Head of, but you will report to a new member of the we who we found for the client at the end of last year (they are ex Roche / Genentech).

Company Culture

The company and its teams are very inclusive and welcoming of new employees on all levels. They are exceptionally reputable, committed to their patients and to delivering on all the promises made with their products. They are very profitable and financially stable and can offer you security and comfort, while allowing you to utilise your RA CMC experience in a positive and collaborative environment in a highly strategic global role.

Company Package

On offer is an excellent and very competitive package and my client will buyout any stock that you might be losing with your current employers. The position comes with a generous bonus and multipliers, as well as an exciting stock plan of their own which starts vesting after your 1^st year at the company.

Working Model

The position can be fully remote working EST hours, as the company will only ask you to visit the office in MA for important meetings and these commutes will always be funded.

To Apply!

To apply for this role, please contact me, Matt Greig on +1-908-332-9157 or send a full CV to my colleague Christian at Christian@AdvTalent.com and we will reply by return. Our team will support you throughout the interview and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration