You play a crucial role in managing regulatory information and documents, ensuring compliance, and supporting marketing authorization applications in international markets.
Anforderungen
- •Pharmacy, Biology or Health/Natural Sciences student
- •Curiosity and passion for Regulatory Affairs
- •Analytical and self-organization skills
- •Excellent communication skills
- •Flexibility to work in a cross-functional team
- •Structured and responsible way of working
- •Good user knowledge of MS Office
- •Very good English language skills
Deine Aufgaben
- •Update RIMS database with procedural information.
- •Ensure RIMS data compliance with SOPs and regulations.
- •Prepare for major RIMS software update and data migration review.
- •Enter regulatory documents in document management software.
- •Use eCTD software for compilation and publishing.
- •Assist in preparing regulatory documents for marketing applications.
- •Draft administrative documents for marketing authorisation.
Deine Vorteile
Open corporate culture
Attractive compensation
Flexible working hours
Job ticket for RMV region
Childcare allowance
Free health-promoting offers
Subsidized cafeteria
Original Beschreibung
****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 Wellpass or the STADA Gym (free of charge)
* Subsidized cafeteria
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.