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Vacancy
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Job Description
Roles & Responsibilities
Independently develop and execute agreed dossier strategy to meet regulatory and business objectives.
- Manage multiple projects simultaneously, handling varying complexity and delivering outcomes on time.
- Conduct thorough data assessments to ensure dossiers are complete, accurate and fit-for-purpose.
- Identify, document and mitigate risks related to submission data and information packages.
- Escalate critical issues to line management when they have business impact and support resolution.
- Review peers dossiers, recommend improvements, and contribute to enhancements of Regulatory processes, policies and systems.
- Act as subject-matter expert on applicable regulations, guidelines and procedures for product registration and manufacturing; provide consultation, training and mentoring to colleagues.
- Build and maintain stakeholder relationships across GSK and externally, share knowledge, and communicate effectively to support project and policy objectives.
Desired Candidate Profile
Basic Qualification:
- Bachelor s degree in pharmacy, chemistry, biotechnology, life sciences or related technical field.
- Knowledge of drug development and manufacturing and supply processes.
- Knowledge of worldwide CMC post-approval regulatory requirements.
- Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager.
- Service orientation, customer-focused.
- Fluent written and verbal English.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Senior Regulatory Specialist
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GlaxoSmithKline
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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