Specialist Global Regulatory Affairs API

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 requests Drug Master File & 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

• Preparation of DMF according to project DMF 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
• 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 preparation
• Continuous monitoring of guidelines FDA EMA EDQM 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 bachelors degree in Pharmacy Chemistry Biotechnology or related studies
• 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 self-disciplined 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
  

Xellia Pharmaceuticals is a specialty pharmaceutical company and a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive heritage in developing manufacturing and commercializing anti-infective products.

Headquartered in Copenhagen Denmark and owned by Novo Holdings A/S Xellia Pharmaceuticals has more than 1400 employees globally including state-of-the-art manufacturing sites in China Denmark and Hungary. Our strong market position is built on more than 120 years of pharmaceutical industry experience.

Further information about Xellia can be found at:
Connect with us onLinkedIn