Regulatory Affairs Associate (CMC Lifecycle)- Temporary for 3 years
Regulatory Affairs Associate (CMC Lifecycle) - Temporary for 3 Years
Location: Sofia, Bulgaria, 1407 Company: Teva Pharmaceuticals Job Id: 67144
We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
Our Team, Your Impact We are searching for qualified and motivated candidates for the role of Regulatory Affairs Associate (CMC Lifecycle)- Temporary position for 36 months, based in Sofia. Junior applications will also be considered, particularly from recent graduates with a pharmaceutical education who have not yet gained professional experience.
About the Position
The RA CMC Lifecycle Associate has the responsibility to compile and maintain the CMC part (modules 2.3 and 3) of the medicinal product dossiers for the worldwide registrations of Teva. As part of this position, the Associate will engage closely with colleagues across regions and functions, contributing to shared goals while embracing different cultures, perspectives, and ways of working.
How You'll Spend Your Day
• Actively participate in meetings related to registration procedures or when CMC expertise is needed.
• Collect and critically evaluate data for inclusion in marketing authorization dossiers.
• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration and respond to queries.
• Actively participate in the change control system and work in line with established processes.
• Prepare the variation packages and other necessary documents as required by the variation process.
• Perform regulatory evaluation and assessment of technical documentation.
• Contribute to renewal applications or annual reports.
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and International markets) and pharmacopoeias.
• Support strategic projects such as technical transfers.
• Ensure that all documents and records pertaining to the RA CMC Lifecycle Department are archived properly.
• Keep departmental database or other tracking systems up to date.
Your Skills and Experience
University degree, preferably be in possession of a master level of education in 'Regulatory Disciplines' or in other area, but pertinent with the field. 2-5 years of experience in CMC Regulatory Affairs or in another scientific role in the pharmaceutical industry. 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. Ability to work in team. Communication skills with internal and external customers. Organisation skills. Accuracy in practice and attention to detail.
How We'll Take Care of You Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria Competitive remuneration bound with performance Additional healthcare insurance Transportation allowance and other flexible benefits Flexible working hours and option to work from home as per the company policy Opportunity for development
Apply tot his job
Apply To this Job
Location: Sofia, Bulgaria, 1407 Company: Teva Pharmaceuticals Job Id: 67144
We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
Our Team, Your Impact We are searching for qualified and motivated candidates for the role of Regulatory Affairs Associate (CMC Lifecycle)- Temporary position for 36 months, based in Sofia. Junior applications will also be considered, particularly from recent graduates with a pharmaceutical education who have not yet gained professional experience.
About the Position
The RA CMC Lifecycle Associate has the responsibility to compile and maintain the CMC part (modules 2.3 and 3) of the medicinal product dossiers for the worldwide registrations of Teva. As part of this position, the Associate will engage closely with colleagues across regions and functions, contributing to shared goals while embracing different cultures, perspectives, and ways of working.
How You'll Spend Your Day
• Actively participate in meetings related to registration procedures or when CMC expertise is needed.
• Collect and critically evaluate data for inclusion in marketing authorization dossiers.
• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration and respond to queries.
• Actively participate in the change control system and work in line with established processes.
• Prepare the variation packages and other necessary documents as required by the variation process.
• Perform regulatory evaluation and assessment of technical documentation.
• Contribute to renewal applications or annual reports.
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and International markets) and pharmacopoeias.
• Support strategic projects such as technical transfers.
• Ensure that all documents and records pertaining to the RA CMC Lifecycle Department are archived properly.
• Keep departmental database or other tracking systems up to date.
Your Skills and Experience
University degree, preferably be in possession of a master level of education in 'Regulatory Disciplines' or in other area, but pertinent with the field. 2-5 years of experience in CMC Regulatory Affairs or in another scientific role in the pharmaceutical industry. 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. Ability to work in team. Communication skills with internal and external customers. Organisation skills. Accuracy in practice and attention to detail.
How We'll Take Care of You Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria Competitive remuneration bound with performance Additional healthcare insurance Transportation allowance and other flexible benefits Flexible working hours and option to work from home as per the company policy Opportunity for development
Apply tot his job
Apply To this Job