retirement pension plan
PoznańPoznań, Greater Poland
- Offer expired 25 days ago
- Remote recruitment
- contract of employment
- specialist (Mid / Regular)
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 specific 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
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
extra social benefits
one shorter working day
sport and recreation cards
canteen for employees at site (with discounts)
flexible working options available for most positions
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) across various markets worldwide.
The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) documentation in support to various applications submitted in affected markets. 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.