דרושים Regulatory Affairs Associate Cmc Lifecycle Fixed-term Contract ב-טבע ב-Hungary, Budapest

• Create, maintain and adapt international registration dossier in line with current trends and legislative changes
• Compile and assess the registration dossier in terms of completeness and compliance with registration requirements
• Actively participate in the change control system and work in line with established processes:
  • Evaluate changes and propose classification and submission strategy in line with applicable regional and local regulations
  • Cooperate with Submission RA functions to align on strategy for submission to authorities in the relevant market
• Prepare the variation packages and other necessary documents as required by the variation process
• Perform regulatory evaluation and assessment of technical documentation intended for inclusion in regulatory submissions, ensuring that the documentation is appropriate for the required purpose and targeted regulatory markets
• Contribute to renewal applications
• Respond to queries (from regulatory authorities, internal departments/affiliates or clients) concerning changes. Manage the process of responding to the
• CMC questions by involving all stakeholders and follow up agreed actions to respond as rapidly and completely as possible
• Work with internal and external partners as required
• Support strategic projects such as technical transfers
• Actively participate in meetings related to registration procedures or when CMC expertise is needed
• Perform punctual and accurate reporting of registration activities in regulatory databases
• Abide by the ICH guidelines and other relevant regulatory provisions
• Represent RA CMC Lifecycle in project teams, as applicable
• Identify and implement process improvements
• Any other duties as required/assigned by the company and/or direct superior

• MSc degree in Pharmacy, Chemistry or Biology
• 2-5 years of experience in CMC Regulatory Affairs
• Knowledge on registration procedures and pharmaceutical regulation
• Working independently with a moderate level of guidance and direction
• Very good command of English, speaking and writing
• Good IT skills
• Excellent organizational and interpersonal communication skills (both written and verbal)
• Work and collaborate remotely with numerous professionals and stakeholders both within and outside the department towards common goals while coordinating various regulatory tasks
• Analytical thinking
• Accuracy in practice and attention to detail.
• Ability to work under pressure and on own initiative

• Competitive salary;
• Benefits packages with a great bonus system;
• Dynamic and professional atmosphere;
• Career development opportunities;

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.