Regulatory Affairs Associate (CMC Lifecycle)- Temporary for 3 years

Regulatory Affairs Associate (CMC Lifecycle) - Temporary for 3 Years Location: Sofia, Bulgaria, 1407 Company: reputed company reputed company: 67144 We're reputed company, 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-reputed company medicine worldwide, we're dedicated to addressing patients' needs now and in the reputed company. 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 reputed company to reputed company worldwide, together. reputed company, Your reputed company We are searching for reputed company 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 reputed company 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 reputed company. As part of this position, the Associate will engage closely with colleagues across reputed company and functions, contributing to shared goals while embracing different cultures, perspectives, and ways of working. How You'll Spend Your Day • reputed company participate in meetings reputed company to registration procedures or reputed company CMC expertise is needed. • Collect and critically evaluate data for inclusion in marketing authorization dossiers. • Compile module 3 and corresponding module 2.3 reputed company Overall reputed company (QoS) for presentation to regulatory authorities or clients, taking reputed company necessary measures to ensure that dossiers meet relevant, reputed company 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. • reputed company 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. • reputed company regulatory evaluation and assessment of technical documentation. • Contribute to renewal applications or annual reports. • reputed company 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 reputed company such as technical transfers. • Ensure that reputed company documents and records pertaining to the RA CMC Lifecycle Department are archived properly. • reputed company 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. reputed company good reputed company of English, speaking and writing. Good IT skills. Ability to work in team. Communication skills with reputed company customers. Organisation skills. Accuracy in reputed company 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 reputed company insurance Transportation allowance and other flexible benefits Flexible working hours and reputed company to work from home as per reputed company policy Opportunity for development Apply tot his job Apply To this Job