Senior Regulatory Specialist, Product Variations Warszawa, mazowieckie

Senior Regulatory Specialist, Product Variations
Warszawa
Warszawa, mazowieckie, Polska

Opis stanowiska pracy

Senior Regulatory Specialist, Product Variations
Warszawa
NR REF. : 1176783

Your responsibilities:

• Managing multiple CMC (Chemistry, Manufacturing and Control) Variations and source transfers for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines products
• Managing routine assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with 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, Global Regulatory Groups and Local Operating Companies in markets worldwide to deliver high quality dossiers on time
• Building and maintaining good relationships with internal and external stakeholders
• Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements
• Identifying the improvement opportunities for CMC Regulatory processes, policies and systems

• Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)
• Bachelor’s or Master's degree in biotechnology, chemical technology, pharmacy, chemistry or other related science or technical field
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
• Attention to detail with emphasis on accuracy and completeness
• Ability to handle multiple tasks, to meet constantly shifting priorities and to schedule work to meet business needs,
• Flexible and analytical thinking to independently provide solutions to issues,
• Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team environment and build relationships across a large organization.
• Excellent written and verbal communication skills in English and Polish

• Flexibility in working mode
• Established job in an international, well-known pharmaceutical company
• Opportunity to work in professional team playing crucial role in introducing the company portfolio to the market
• Opportunity to work within the company standards and documentation applied globally
• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
• Flexible working hours