Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers, labeling outputs, license maintenance, regulatory information.
GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).
The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) in support to various applications.
Regulatory Specialist is accountable for delivering MSRs documentation in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses and new applications worldwide.
Key responsibilities :
Managing Market Specific Requirements for Finished Products and Active Pharmaceutical Ingredients in various areas
Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets
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
Understand external / internal Regulatory environment
Building good relationships with internal and external stakeholders
Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)
Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field
Attention to detail, excellent organization and time management skills
Excellent written and verbal communication skills in English and Polish
Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
Preferred Qualifications :
Knowledge of worldwide CMC regulatory requirements
Work experience in an international environment would be an additional advantage
Work experience in biopharma and vaccines is highly welcomed
We offer :
Stable and interesting job in one of the leading global healthcare companies.
Access to newest technologies and solutions.
Friendly work environment and great atmosphere in our teams.
Possibilities of development within the role and company’s structure.
Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).
Corporate culture based on our values : patient focus, integrity, respect and transparency.
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