Senior Regulatory Specialist New Registration CMC CMC Excellence

Senior Regulatory Specialist New Registration CMC CMC Excellence

The CMC Regulatory Affairs group at GSK is located across multiple sites and plays a crucial role in ensuring the approval and continuous supply of medicines. Within the CMC RA group the New Registrations CMC team bring together the operation and aspects for key regulatory deliverables such as new chemical entity product expansion dossiers and CTA submissions. The New Registrations CMC team provide regulatory support across for development and registration of new pharmaceutical biopharm and vaccines products.

Your Responsibilities:

• Managing multiple CMC new files and CTA assignments for Pharma Biopharm and Vaccines products including response to questions from Agency;
• Define and agree regulatory strategy complete data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements;
• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements;
• Effective communication also in a digital context including virtual meetings and digital platforms;
• Act as subject matter expert in regulatory processes;
• Evaluating and implementing innovative solutions for CMC Regulatory processes policies and systems;
• Supporting digital transformation through active participation in building digital skills;

Why you

We are looking for professionals with these required skills to achieve our goals:

• Extensive experience in regulatory affairs pharmaceutical industry (familiarity with CMC regulatory procedures and ICH CTD documentation)
• Bachelors or Masters degree in biotechnology pharmacy chemistry or other related science or technical field
• Attention to details excellent organization and time management skills
• Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
• Understanding of the pharmaceutical industry drug development environment and regulatory processes.
• Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts
• Mindset that embraces digital transformation and innovation by being adaptable forwardthinking and eager to explore new possibilities in the everevolving digital landscape
• Veeva Vault knowledge would be an asset

Why GSK

At GSK we offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies
• Hybrid work 2/3 days per week from the office)
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance recognition awards for additional achievements and engagement holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
• Sports cards (Multisport)
• Possibilities of development within the role and companys structure
• Personalized learning approach (internal trainings mentoring access to online training platforms: Keep Growing Campus LinkedIn Learning Business Skills Harvard Manage Mentor Skillsoft and external training)
• Extensive support of work life balance (flexible working solutions short Fridays option health & wellbeing activities).
• Supportive community and integration events
• Modern office with creative rooms fresh fruits every day

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As an Inclusive employer we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team atto discuss your needs.