General?Summary?Responsible?for?the?regulatory?Chemistry,?Manufacturing?&?Controls?(CMC)?aspects?of?the?company’s?international?pharmaceutical?product?portfolio?from?early?development?(candidate?selection)?and?throughout?the?commercial?lifecycle.?Primary?Responsibilities???Uses?expertise?of?global?regulatory?affairs?(RA)?CMC?regulations?and?guidelines?to?ensure?regulatory?compliance.???Responsible?for?the?evaluation?of?change?proposals.???Oversees?the?team?that?defines?and?executes?CMC?content?requirements?for?regulatory?submissions.???Leads?the?evaluation?of?change?proposals?for?regulatory?impact?and?filing?requirements.???Establishes?and?maintains?effective?direct?communication?with?leadership?teams?and?key?stakeholders.???Acts?as?point?of?contact?for?all?leadership?teams?on?regulatory?CMC?requirements.???Provides?regulatory?expertise?for?CMC?requirements?on?project?teams.???Reports?project?status?and?issues?to?leadership?and?works?collaboratively?as?necessary.???Expert?knowledge?of?regulatory?CMC?requirements?for?global?drug?development?and?post-market?support?initiatives.???Expert?knowledge?of?global?regulatory?affairs?as?well?as?understanding?of?European,?US?and?international?regulations?relative?to?systems.???Expert?understanding?of?how?the?pharmaceutical?industry?works???Excellent?written?and?oral?communication?skills?required???Expert?ability?to?efficiently?determine?the?root?cause?of?a?problem,?identify?viable,?risk-balanced?solutions?and?implement?such?solutions?appropriately.?Bachelor’s?degree?in?relevant?field?of?study.?Master’s?degree?preferred.?Typical?Minimum?Experience:?12?years?of?relevant?experience