Job Description

Job Purpose :

The Manager, Regulatory MSR Coordination has managerial responsibility for a number of direct reports as well as accountability for completion of assigned work in their regulatory area. The Manager is the point of escalation for resource or quality considerations.

The Manager, Regulatory MSR Coordination is accountable for the efficient management and delivery of Market Specific Requirements and Sample/Certificate Delivery from his /her team.

Key Responsibilities :

• Manage HR aspects for a team of direct reports including recruitment
• Manage workload within assigned team and work with other team leads within functional area to address resource challenges
• Provide peer review and quality check support as requested and able
• Serve as point of escalation for team members
• Maintain a workload in area of responsibility
• Participate in quality or continuous process improvement activities related to area of responsibility or as requested
• Maintain appropriate organizational networks
• Recognizes matters that affect corporate or agency policies and escalates issues with high business impact or risk.
• Manage work allocation and preparation of Market Specific Requirements package (MSR for Central and Regional) for regulatory submissions
• Support / coach team to liaise with MSR suppliers & customers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
• Oversight on timely delivery and appropriate quality for MSR data package.
• Oversight to ensure appropriate archival of MSR data package.
• Ensure effective communication on the availability of MSR data package to LOC.
• Organize dispatch of MSRs.
• Oversee tracking systems are updated (e.g., Veeva) as defined by process documents.
• Develop Subject Matter Expert (SMEs) by providing appropriate guidance and knowledge
• Proficiently use intelligence resources to determine MSR data package requirements.

Educational Background :

Bachelor\xe2\x80\x99s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment

Job-Related Experience :

• 10-12 years of experience in handling MSR or related responsibilities within regulatory function
• Managed an operational/production team of 5 or more people that successfully delivered outputs to time and quality over a sustained period
• Worked within a global organization
• Operated a major information management system in support of a large group or organization
• 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

Other Job-Related Skills/Background

• Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers
• Can communicate effectively in English.
• Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.

• Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
• Ability to define and implement new processes and quality initiatives with an awareness of relevant controls and impacts.

Highly developed interpersonal, presentation and communication skills with established internal and external networks.

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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