Your mission
- As a member of the Regulatory Affairs team, you are primarily responsible for preparing
and applications for national and international approvals - You will provide regulatory support for the strategic development, approval and life cycle management of medicinal products in order to ensure compliance with regulatory and legal requirements for the assigned products
- You will implement local regulatory changes and update product information texts in accordance with the legal national and international requirements
- In the CMC area, you will be responsible for creating Module 3 (2.3) as part of new approvals and their maintenance in life cycle management, including preparation of the corresponding documentation for variations (including the regulatory evaluation of change control applications)
- You will support development projects by providing regulatory advice, evaluate approval strategies and prepare the associated regulatory documentation
- At hameln pharma, you will act as a link/contact person to other specialist departments and are open to questions on all aspects of drug approvals
- You will record all regulatory processes, including electronic document filing and maintenance of regulatory databases
Your profile
- You have successfully completed a degree in natural sciences or a comparable degree or a qualification as well as several years of professional experience in the pharmaceutical industry in the maintenance of
marketing authorizations - Knowledge of European regulatory requirements as well as international guidelines for the worldwide
drug authorization - You communicate confidently in German and English and have the ability to work in an intercultural team
- You are confident in using MS Office applications and have initial experience with document management systems (e.g. docuBridge)
- You work in a solution-oriented manner, with a high level of commitment and
sense of responsibility - You are characterized by a structured, organized and very precise and conscientious way of working
- You have an independent and team-oriented working style and proactive thinking with a hands-on mentality
Why us?
- Comprehensive, industry-specific onboarding and independent work in your field of activity
- A good work-life balance thanks to flexible working hours and the option of mobile working
- 30 days\' vacation and time off in special life situations
- Fair, attractive remuneration as well as a company pension allowance and capital-forming benefits
- Individual training opportunities and support for professional and personal development
- An attractive, modern working environment with ergonomic workstations and the option to lease a job bike
