Regulatory Affairs Associate (CMC Lifecycle)

Regulatory Affairs Associate (CMC Lifecycle)

Teva

Opava, Czech Republic

How You’ll Spend Your Day

• Create, maintain and adapt international registration dossiers in line with current trends and legislative changes
• Compile and assess registration dossiers in terms of completeness and compliance with registration requirements
• Prepare variation packages and other necessary documents as required by the variation process, with particular focus on technical transfers and other complex changes
• 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
• 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
• Respond to queries from regulatory authorities, internal departments/affiliates or clients concerning changes. Manage the process of responding to CMC questions by involving all stakeholders and following up on agreed actions to respond as rapidly and completely as possible
• Represent RA CMC Lifecycle in project teams, as applicable
• Work with internal and external partners as required
• Contribute to renewal applications
• Perform punctual and accurate reporting of registration activities in regulatory databases
• Identify and implement process improvements
• Abide by the ICH guidelines and other relevant regulatory provisions
• Any other duties as required/assigned by the company and/or direct superior

Your Skills and Experience

• MSc degree in Pharmacy, Chemistry or Biology
• Minimum of 2 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

Also Good to Have

• Experience with technical transfer projects, site transfers, source changes, manufacturing site changes or other complex CMC lifecycle changes would be considered an advantage
• Understanding of pharmaceutical manufacturing processes, GMP principles and regulatory documentation requirements
• Ability to identify potential regulatory risks and contribute to practical mitigation actions
• Experience with regulatory databases, document management systems or submission planning tools
• Previous experience in a multinational, matrix organization would be considered an advantage
• Interest in process improvement, standardization and digital ways of working