About the Job

As a Specialist in Global Regulatory Affairs API you will be part of a skilled, multi-cultural, and professional team in which your main responsibility will be handling of global regulatory life cycle activities related to the APIs 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 projects. The tasks will require interaction with different departments globally and will give you an opportunity to expand your knowledge on all 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 Quality Overall Summaries under supervision of more expirienced colleagues
• Handling deficiency letters received from Regulatory Agencies, ensuring proper implementation of any changes in manufacturing or control processes with support of more expiriieced collegues if needed
• Handling the queries received from Customers from regulatory and technical perspective with support of more expiriieced collegues if needed
• Prepare, retrieve, review for accuracy, completeness and compliance with regulations, approve and collect all 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 client demands
• Contribute to the product development and maintenance of the existing portfolio from regulatory aspects
• Deap participation in manufacturing site technical transfers (internal and external) with regulatory expertise with support of more expiriieced collegues 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 expirienced colleagues
• SOP/WI preparation
• Continuous monitoring of guidelines, FDA, EMA, EDQM, ANVISA and MHRA home page and ensure their timely implementation
• Work in EDMS/TrackWise
• Continuous development in the area of regulatory affairs
• Providing all needed regulatory support, including opinion or advice to all other stakeholders
• Participating in multifunctional team meetings

What We Expect

• Minimum a bachelor's degree in Pharmacy, Chemistry, Biotechnology or related studies (master’s degree is an advantage)
• 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
• Capatibility to evaluate change controls from thier areas independently (use of Trackwise system for handling change controls is advantage)
• Thorough proficiency in MS Office
• Must work well under deadlines and have excellent attention to detail
• Must be selfdisciplined to plan, schedule and arrange own activities in alignment with projects
• Demonstrated ability to handle multiple tasks in a fast-paced environment
• Proactive working approach and developed stakeholder management skills
• Excellent interpersonal and communication abilities

What We Offer

• Competitive compensation and benefit package
• „Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment
• Home office opportunity

Location

Budapest

Xellia Pharmaceuticals is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union 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 commercial 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 progress.

With more than 1100 employees, our impact starts from within. We offer a workplace where ideas, curiosity, and initiative thrive, and where your role evolves with your ambition. Instead of rigid structures, we provide real responsibility, freedom to explore, and support to grow. Together, we shape not only the future of our company and the development of our people, but also the health of communities worldwide.

Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn