Gsk
Biopharma
RegulatoryCMCManager
Neural analysis suggests this role is
optimal for Senior candidates.
“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
Full Job Description
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: [Our approach to R&D](https://www.gsk.com/en-gb/innovation/) Position Summary * Managing direct reports. * Ensures efficient delivery and high quality of Rx and/or Vx CMC projects (including technical content as well as Market Specific Requirements (MSRs)). * Ensures effective regulatory processes are followed to assess and assure the quality, reliability and consistency of all data used in regulatory submissions. * Defines and implements objectives for the team members to ensure business continuity and to address development needs. * Drives continues improvement for defined and new processes. Key Responsibilities * Manage HR aspects for a team of direct reports including effective recruitment, training and development. * Efficiently plan, prepare and deliver of CMC projects in support of GSK’s established product portfolio for both Rx and/or Vx products. * Provide quality check support as requested and able. * Serve as point of escalation for team members and stakeholders. * Recognize matters that affect corporate or agency policies and escalates issues with high business impact or risk. * Participate in quality and continuous process improvement activities related to area of responsibility or as requested. * Work efficiently in partnership with CMC RA, PSC and LOCs to ensure smooth delivery of CMC
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