Gsk
Biopharma
RegulatoryCMCManager
“Regulatory CMC Manager at Gsk. Skills: Regulatory Affairs, CMC, Team Management. Manage direct reports. Ensure efficient delivery of Rx and/or Vx CMC projects”
What You'll Achieve.
accelerating significant assets that meet patients’ needs; highest probability of success; positively impact the health of 2. 5 billion people; deliver consistently within a technically complex and highly regulated environment
Industry & Context.
Problem Solving
What They're Looking For.
Must Have
10 + years of experience in Regulatory Affairs in CMC area or related responsibilities for Rx and Vx, 2+ years managing teams delivering CMC outputs, Managed a team of more than 5 people that successfully delivered outputs to time and quality over a sustained period, Worked within a global organization across different geographical locations, Successfully performed within a regulated or quality-critical environment, Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products, Successful and sustained delivery of a significant number of CMC packages including a broad range of submission types across EU/US and International markets
Nice to Have
some experience of this is preferred
What You'll Do.
Manage direct reports
Ensure efficient delivery of Rx and/or Vx CMC projects
Ensure effective regulatory processes are followed
Define and implement objectives for team members
Drive continues improvement for defined and new processes
Manage HR aspects for a team
prepare and deliver of CMC projects
Provide quality check support
Serve as point of escalation
Recognize matters that affect corporate or agency policies
Escalate issues with high business impact or risk
Participate in quality and continuous process improvement activities
Build CMC competencies in team
analyze and report on team performance
How You'll Work.
Team & Collaboration
Work efficiently in partnership with CMC RA, PSC and LOCs
Communication Scope
Communication
Process & Methodology
Manage CMC projects
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