Regulatory Manager Regional Projects CMC GlaxoSmithKline

Regulatory Project Manager , Regional Projects Team, CMC Excellence

Within the CMC RA group, the Regional Projects team bring together the operation and execution aspects for key regulatory deliverables for new Directives and Guidelines issued in Regions such as the implementation of eCTD Baselining, general Baselining, Localisation initiatives, and Re- Registrations. The Regional Projects team provide regulatory support across the Regions to deliver Submissions as stipulated in the new HA Directives for pharmaceutical, biopharm and vaccines products.

As Regulatory Manager, Regional Projects CMC you will have managerial responsibility for a direct reports as well as accountability and lead for the completion of assigned projects in the CMC Rx and Vx regulatory area. You will work with Head and Manager of Regional Projects as well as with Establish Products Teams to deliver Team s objectives.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• Managing people aspects of a team of direct reports to create and sustain an efficient and motivating working environment

• Take accountability for tracking, analyzing and reporting of team performance against departmental KPIs

• Ensure proper escalation for resource or quality considerations

• Independently assess, manage, and/or drive the CMC strategy, coordinate, timely preparation, and author multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the Regional Directives and evolving regulatory requirements.

• Understand internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to Localisation projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC.

• Ensure adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.

• Ensure adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions.

• Identify risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.

• Contribute to, and lead (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems.

• Ensure information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.

• Independently manage the completion of data assessment, ensure all appropriate CMC regulatory aspects, serve as dossier approver, identify improvement opportunities, and confidently execute a dossier that is fit for purpose per agreed dossier strategy and timelines.

Why you?

Basic Qualifications:

• Master s degree or higher in a relevant scientific discipline.

• Experience in an international regulatory environment or working with multiple markets.

• Sound understanding of pharmaceutical industry and regulatory processes with expertise in CMC area

• Project Management experience

• Capability to build and maintain a team

• Fluent English

• Strong interpersonal and communication skills

• Ability to perform multiple tasks, set the right priorities to deliver objectives on time

• Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.

• Exceptional flexibility and growth mindset

• Change management and strong learning agility

Preferred Qualifications:

• Well-developed leadership skills,

• Negotiation and problem solving skills,

• Practical knowledge of risk management,

• Veeva Vault knowledge would be an asset