Senior Regulatory Specialist CMC
- Luboń, Poland
Site Name: Warsaw, Poznan Grunwaldzka
Posted Date: Jun 11 2020
The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznan team. The purpose for the role will be leading or participating in global CMC Variation projects (for Pharma and Vaccines Products), timely maintenance of post approval CMC changes for Finished Product and Active Pharmaceutical Ingredients, providing expertise and support to Local Operating Companies with respect to post approval changes and responses to Regulatory Agency questions about Products.
As we are expanding our structure, we are looking for several candidates to join us.
- Managing multiple CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients
- Define and agree strategy, complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions, US and International countries)
- 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
- Building good relationships with internal and external stakeholders
- Ensuring all appropriate regulatory aspects for product release and stability are in place, to ensure continuity of market supply
- Act as subject matter expert in regulatory processes
- Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)
- Bachelor's 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 communication skills in English and Polish
- Ability to think flexibly in order to meet constantly shifting priorities and timelines and to independently provide solutions to issues
- Well-developed understanding of the pharmaceutical industry, drug development environment
- Well-developed understanding of regulatory process (e.g. experience in managing CMC global Variation Projects)
- Established job in an international, well-known pharmaceutical company
- Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
- 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
- Canteen for employees at site (with discounts).
- Flexible working hours
- Partly remote work
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