Working Student Regulatory Global Specialty / Biosimilar Development (f/m/d)

"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Working Student Regulatory Global Specialty / Biosimilar Development (f/m/d)

Bad Vilbel | Germany (DE) | Full-time | Fix-term | Portfolio & Product Development | Internships / Students

What you can expect

• You ensure the update of regulatory information management system (RIMS) database by entering procedural information for all STADA biosimilar products
• You support in the alignment of information entered in the RIMS to ensure compliance with internal SOPs and pharmaceutical law
• You support the preparations for an upcoming major RIMS software update and review correctness of data migration
• You enter regulatory documents in document management software and use eCTD compilation and publishing software
• You assist in the preparation of regulatory documents needed for marketing authorisation applications in international markets
• You assist in the preparation of administrative documents needed for marketing authorisation applications (e.g. cover letter, letter of authorisation)

Who we are looking for

• You are a Pharmacy, Biology or another Health/ Natural Sciences student (Bachelor, Master or Doctorate)
• You are curious, passionate about learning about the Regulatory Affairs role in a multinational pharmaceutical company
• You bring analytical and very good 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 STADA affiliates associates
• You have a structured and responsible way of working
• You have a 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 your personal development
• Attractive compensation in line with industry standards
• Flexible working hours that are compatible with your lecture times
• Job ticket for the RMV region
• Childcare allowance
• Health-promoting offers such as or the STADA Gym (free of charge)
• Subsidized cafeteria

We look forward to receiving your application via our . At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to . We will consider requests to work part-time on an individual basis. Please contact us in advance by e-mail (.) and let us know how many hours per week you would like to work. #LI-NS1 #LI-HYBRID

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.