Senior Specialist, Client Facing Scientific Consulting
Core
Provide on-site regulatory support to clients, managing marketing authorizations and CMC documentation for human and veterinary medicinal products.
Role type
Senior Specialist, Client Facing Scientific Consulting
Builds
Regulatory submissions and client project delivery for pharmaceutical and medical device products
Domain
Life Sciences / Regulatory Affairs / CMC
Deliverable
client delivery
Required skills
CMC documentation, regulatory intelligence, client relationship management, project planning, problem solving, training junior colleagues
Preferred skills
Pharmacovigilance certification, regulatory affairs certification, quality management certification
Technologies
None stated
Responsibilities
Develop and maintain client relationships; Participate in regulatory processes for marketing authorizations; Support preparation and review of CMC documents; Communicate with clients and Health Authorities; Support planning and execution of client projects; Provide operational insights for commercial activities; Deliver on-site regulatory support to GCS clients
Seniority
Senior, hands-on IC