Informacje o stanowisku

Opis stanowiska pracy

Regulatory Specialist, Product Variations.
Polska
NR REF.: 1186423

Your responsibilities

• Managing multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharma, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)
• Managing assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with the company 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 Supply Chain, 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 Master39s 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

• Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs), flexible working hours
• Established job in an international, well-known pharmaceutical company
• Opportunity to work in professional team playing crucial role in maintaining the company portfolio on the markets
• 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)
• Recognition awards for additional achievements
• Supportive & friendly working environment
• Possibilities of development within the role and company’s structure

If you39re interested in this role, click 39apply now39 to forward an up-to-date copy of your CV, or call us now.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

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