We have a current opportunity for a Senior Managers to Executive Directors Regulatory CMC on a permanent basis. The position is remote with occasional meeting based in Boston.
Qualifications:
Experience liaising with Regulatory Agencies: led in Agency Interactions and product development meetings, international experience preferred.
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
Demonstrated leadership, problem-solving ability, flexibility and teamwork.
Good judgement in elevating and communicating actual or potential issues to line management.
Excellent written and oral communication skills.
Experience of active participation in Agency/Industry groups/forums expected.
If this sounds like you and you are interested in joining one of the best biopharmas in the world then apply now!
