Job Description

This role is based in Washington DC, and is open to US candidates willing to live in or near as well as work in central Washington DC. Relocation is considered for the right individual.

My client is part of a major healthcare and pharmaceutical group, with this business unit focused predominantly on mAbs and biosimilars. This role will be based as a guest within their Advocacy Office, but is very much a regulatory CMC expert role, helping to with the team, gain successful outcomes by ensuring the timely preparation, submission and review of primarily BLAs but also IMPDs, as well as co-leading pre submission and review meetings with the US FDA, EMA, and other major agencies.

The company builds CTDs using a CRO / Consultancy, so this is hands-on but not in that way; it is in terms of guiding the teams through the regulatory and CMC strategy to develop the right data packages for the regulators, preparing the responses for CMC for HA queries, working with assessors to resolve complexities, all the while, acting as a conduit to the internal experts and CMC sub-teams (who are impressive and have significant track records in their own right).

The company is very active with BLA filings, with more coming through, so during the downtimes, there are another 10 or so programmes, to help shape or author RA CMC strategies for, which might include helping to hire and coach other regulatory CMC team members.

Your Experience

• You will have strong experiences in managing US or EU CMC RA Strategies for mAbs and proteins
• You will have knowledge of various topics including biosimilars, comparability, mammalian cell, and analytics
• You will have led at least one major BLA submission preparation as the RA CMC Lead for the USA minimum, possibly other regions as well, and direct experience of developing CMC RA strategy for NBEs in development
• You will have the type of communication skills and attitude, that endear collaboration, people listen to you because you take time to listen and then explain
• You have direct experience of preparing for and co/leading US FDA meetings or FDA Telecoms.

Package

The company are offering a strong Director level US package, including bonus and health insurance; the company will sponsor a relocation for the right applicant, but equally individuals able to commute to Washington DC, are also invited to apply!

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To apply for this role, please contact me, Theo Moore, on +442078013384 / +447918195166 to find out more about this role, alternatively, send a full CV to theo@advtalent.com and I will respond to you by return.

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