Regulatory Specialist - Biosimilar Development
Care for the health of people worldwide as a trusted partner. Our mission is to improve the well-being of patients, doctors, and pharmacists through our range of generics, consumer health products, and specialty pharmaceuticals.
* We have around 13,000 employees who live by our values of Integrity, Entrepreneurship, Agility, and One STADA.
Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility, and One STADA.
We are on an exciting growth journey and want to shape the future successfully together. Our diversity promotes creative ideas, expanded experience, and innovative strength. We focus on equal opportunities, respectful cooperation, and an inclusive working environment.
About the Job
You will update the regulatory information management system (RIMS) database by entering procedural information for all STADA biosimilar products. You will support the alignment of information entered in RIMS to ensure compliance with internal SOPs and pharmaceutical law. You will prepare administrative documents needed for marketing authorization applications.
Requirements
* You are a Pharmacy, Biology or another Health/Natural Sciences student (Bachelor, Master or Doctorate)
* You are curious and passionate about learning about the Regulatory Affairs role in a multinational pharmaceutical company
* You bring analytical and self-organization skills to handle activities independently
* You have excellent communication skills, written and verbal
* You are flexible to work in a cross-functional team (Development), with close interaction with Regulatory Operations and associates
* You have a structured and responsible way of working
* You have good user knowledge of common MS Office tools
* You have very good English language skills, knowledge in additional language(s) is beneficial
What We Offer
* An open corporate culture with fast decision-making processes and a lot of potential for personal development
* Attractive compensation in line with industry standards
* Flexible working hours that are compatible with your lecture times
* Job ticket for the region
* Childcare allowance
* Health-promoting offers such as the STADA Gym (free of charge)
* Subsidized cafeteria
Other Opportunities
We are always looking for motivated talents who can strengthen our team with their expertise and personality.