Junior Regulatory Specialist
The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznan team. The purpose for the role will be 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.
Junior Regulatory Specialist is accountable for preparing and compiling regulatory dossiers, delivering market specific requirements (MSRs) in line with existing business needs, strategies, goals and objectives in order to support GSK's product licences worldwide.
• Managing CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients.
• 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.
• Building good relationships with internal and external stakeholders.
• Bachelor's degree in chemistry, pharmacy or other related science or technical field
• Attention to detail, excellent organization and time management skills.
• Very good written and verbal communication skills in English.
• Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues.
• Strong will to learn new things
• Ability to organize your own work schedule and to keep deadlines,
• Work experience in fields related to regulatory affairs would be an additional advantage.
• Established job in international, well-known pharmaceutical company.
• Wide range of benefits (Medical Plan, Life Insurance, Sport and recreation cards, Recreation allowance etc.)
• Canteen for employees at site (with discounts).
• Flexible working hours.
• Partly remote work.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you very much for your interest in development opportunities with GlaxoSmithKline.
You may apply for this position online by selecting the Apply now button.
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