This reputable leader in the pharma / biotech space is currently looking for a high achieving Regulatory CMC Director to join their established and dynamic team to support with the registration of large molecule products.
With several products nearing registration phase, they require a competent RA CMC strategist who has led pre-submission CMC activities globally.
Manages regulatory CMC aspects including overseeing preparation and submission of CMC submissions supporting CTA’s and MAA’s appropriate to phase of development
Manage HA interactions (EMA / FDA) for information requests, briefing books and IMPD’s
Advise project teams on CMC requirements, issues and ways to overcome them on complex situations
Evaluate CMC documentation from other departments
Mentor more junior team members
8+ years industry experience in Regulatory CMC
Hands on experience with EMA / FDA
Proven ability to product high-quality CMC documentation for complex molecules (including Biologics)
Experience in CMC development activities
Fluency in English is essential, other languages are beneficial
Ability to work in a dynamic company