Regulatory Project Manager, New Registration CMC GlaxoSmithKline

Independently assesses, manages, and/or drives the CMC submission deliverables, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for clinical trials, 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 evolving regulatory requirements

• Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC
• Ensures 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
• Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions
• Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities
• Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches
• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems
• Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact
• Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary
• Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines
  
  What we offer:
• Performance with Choice flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
• Established job in an international, well-known pharmaceutical company.
• Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.
• Opportunity to work within GSK standards and documentation applied globally.
• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
• Supportive & friendly working environment