Specialist Global Regulatory Affairs API - XELLIA Gyógyszervegyészeti

Feladatok:

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 experienced colleagues

Handling deficiency letters received from Regulatory Agencies, ensuring proper implementation of any changes in manufacturing or control processes with support of more experienced collegues if needed

Handling the queries received from Customers from regulatory and technical perspective with support of more experienced 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

Deep participation in manufacturing site technical transfers (internal and external) with regulatory expertise with support of more experienced 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 experienced 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

Elvárások:

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

Capability to evaluate change controls from their 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

Amit kínálunk:

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