Expiry Date: 24-01-2023
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
New York County
Location: Remote – If you are based in New York.
We have a NEW Snr Manager grade Regulatory Affairs CMC role where the focus will be on your strategic input and your strategic leadership for development products with our Global Bio/Pharmaceutical client who have a well-deserved reputation for providing excellent staff training and joined up development opportunities, enabling their Regulatory CMC team members to always grow within the organisation and take on new levels of responsibility.
Our client is well known across the industry for showing true innovation across all major modalities and formulations, and they offer strong compensation packages for R&D staff including a good bonus and a generous stock package at Snr Manager grade, which is quite rare.
They are now recruiting for a Regulatory Affairs CMC professional, confident and happy to be at Snr Manager level, who has strong experiences in NDA/MAA/IND/IMD’s for a strategic role, focused initially on products in mid-development for the US and EU markets - but with an eye on the initial registration(s) and then the next wave of Global submissions. So, the role is Regulatory CMC leadership and strategic input from development through to first and initial registration (US & EU) for small molecules.
You will be responsible for actively contributing to the development and implementation of regulatory CMC strategies for developmental and registration ready products, serving as the regulatory representative on project teams, and serving as the regulatory contact with relevant regulatory authorities.
You will Identify and assess regulatory risks for assigned products and coordinate all aspects of regulatory submissions, participating and contributing to Health Authority meetings and leading regulatory CMC responses for your products.
The Ideal Candidate:
The ideal candidate will have a strong background in authoring Module 3 documents for NDA/MAA/IND/IMD’s but now enjoy providing more strategic leadership for their projects.
On offer is the opportunity to work for a dynamic and highly innovative Global Bio/Pharmaceutical company and receive a great package including a strong basic salary, high annual bonus and a lucrative stock plan with a very generous vesting period!
This role can be fully remote, and reports into a highly engaging and very experienced Snr Director of Regulatory CMC, who could be described as a great mentor and teacher!
Please contact me, Theo Moore or Roland Schnapka on 908.348.6714 or send your CV to CV@AdvTalent.com and we will immediately reply with details on how we will progress your application.