CMC Regulatory Affairs Team Lead

Description

Position: CMC Regulatory Affairs Team Lead
Start: ASAP
Salary: excellent rate per hour
Location: Uxbridge, Greater London, UK.

-Responsible for the CMC regulatory activities of assigned projects across dosage forms.
-May represent Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing regulatory advice and guidance to Preclinical Development (PCD), Biopharm, Global Manufacturing and Supply (GMS), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Office of the Chief Medical Officer (OCMO) to produce appropriate CMC components for global regulatory dossiers with appropriate guidance from supervisor.
-Understands regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceuticaCMCroducts, to expedite submission, review and approval of global CMC applications.
-Thereby, with management oversight, ensuring all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply. Ensuring information submitted in marketing applications meets regional requirements, allowing maximum GMS flexibility with minimal unanticipated questions.
-Manages routine multiple project assignments/teams simultaneously and provides data assessment and conclusions within the department with line manager support.
-Identifies risks associated with submission data and information packages.
-Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
-Understands internal/external CMC Regulatory environment.
-Identifies opportunities to influence internal CMC Regulatory and/or GMS environment.
-Regular communication with line manager to help identify any CMC issues with business impact.

Requirements:

Bachelors degree.(Chemistry, pharmacy or closely related science bachelors degree.)
Regulatory Affairs Certification (RAPS). Knowledge of drug development and manufacturing and supply processes. Knowledge of worldwide CMC regulatory requirements.