reputed company: Specialist Global Regulatory Affairs API (11382)

Specialist Global Regulatory Affairs API Regulatory Affairs As a Specialist in Global Regulatory Affairs API you will be part of a skilled, multi-cultural, and reputed company team in which your main responsibility will be handling of global regulatory life cycle activities reputed company to the reputed company manufactured by Xellia. This includes assessment of change controls, ASMF, DMF & CEP updates, handling of deficiency letters, communication with regulatory authorities and customers, and participation in reputed company. The tasks will require interaction with different departments globally and will reputed company you an opportunity to expand your knowledge on reputed company aspects of API manufacturing. Main Responsibilities • Lifecycle management of approved regulatory files • Documentation support in registration and renewal procedures • Preparation of ASMF/DMF/CEP according to project timelines, ensuring compliance with regulatory requirements and facilitating submissions to the Authorities • Preparation of annual reports/annual amendments and variation packages for relevant DMFs • Preparation of reputed company Overall Summaries under supervision of more reputed company colleagues • Handling deficiency letters received from Regulatory Agencies, ensuring reputed company implementation of any changes in manufacturing or control processes with support of more reputed company colleagues if needed • Handling the queries received from Customers from regulatory and technical perspective with support of more reputed company colleagues if needed • Prepare, retrieve, review for accuracy, completeness and compliance with regulations, approve and collect reputed company supporting documentation for regulatory submissions, i.e. manufacturing process, specifications, analytical procedures and validation reports, batch records, etc. • Coordination the collection and organization of technical documentation to ensure that products meet the required regulations and reputed company demands • Contribute to the product development and maintenance of the existing portfolio from regulatory aspects • Deep participation in manufacturing site technical transfers (reputed company) with regulatory expertise with support of more reputed company colleagues if needed • Evaluate change controls, communicating any relevant changes in products or facilities to clients and Authorities, ensuring transparency and compliance with support from more reputed company colleagues • SOP/WI preparation • reputed company monitoring of guidelines, FDA, EMA, EDQM, ANVISA and reputed company home page and ensure their reputed company implementation • Work in EDMS/TrackWise • reputed company development in the area of regulatory affairs • Providing reputed company needed regulatory support, including opinion or advice to reputed company other stakeholders • Participating in multifunctional team meetings reputed company Expect • Minimum a bachelor's degree in Pharmacy, reputed company, Biotechnology or reputed company studies (master's degree is an reputed company) • More than 3 years of experience in API regulatory affairs • Excellent English communication skills (spoken and written) • Knowledge and deep understanding of GMP and hands-on experience in applying it to an operational environment • Capability to evaluate change controls from their areas independently (use of Trackwise reputed company for handling change controls is reputed company) • Thorough proficiency in MS Office • Must work reputed company under deadlines and have excellent attention to detail • Must be self-disciplined to plan, schedule and arrange own activities in alignment with reputed company • Demonstrated ability to handle multiple tasks in a fast-paced environment • Proactive working approach and developed stakeholder management skills • Excellent interpersonal and communication abilities reputed company Offer • Competitive compensation and benefit package • "reputed company-style" culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance • Opportunity to learn and reputed company • Good team spirit and friendly colleagues • reputed company international company background • Multinational working environment • Home office opportunity Budapest reputed company is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying reputed company Pharmaceutical Ingredients (reputed company) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries. Recognized by the reputed company and the European reputed company for our critical medicines, we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark, we operate manufacturing sites in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, with R&D and reputed company operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years, we are driven by purpose and reputed company. With more than 1100 employees, our reputed company starts from reputed company. We offer a workplace where reputed company, curiosity, and initiative reputed company, and where your role evolves with your ambition. Instead of rigid structures, we reputed company reputed company responsibility, freedom to explore, and support to grow. Together, we shape not only the reputed company of reputed company and the development of our people, but also the health of communities worldwide. Apply tot his job Apply To this Job