Regulatory Affairs Manager (m/f/x) | North Germany area
In this position you will be mainly responsible for assigned projects throughout all project phases including you act as an interface between Quality Management, Clinical Development, and other departments.
What will your tasks as "Regulatory Affairs Manager (m/f/x)" be?
- Execution of approval processes (national procedures, DCP/MRP) and life cycle management both within and outside the EU (e.g., CIS countries).
- Development of approval dossiers and product information texts.
- Participation in responding to regulatory authorities' inquiries and deficiency reports.
- Compilation of approval dossiers as eCTD sequences (using DocuBridge).
- Creation and verification of packaging materials.
Your requirements as "Regulatory Affairs Manager (m/f/x)"?
- Mind. 3 years of experience in pharmaceutical product approval for human medicines.
- Successful completion of a pharmaceutical, medical, or natural science education or degree.
- Natural scientists (pharmacist, biologist, chemist, medical doctor, etc.).
- Vocational training (pharmacy assistant, laboratory assistant, medical technical assistant, clinical trial assistant, etc.).
- Proficiency in both German and English, spoken and written.
- IT proficiency: document management systems, EU databases, MS Office.
- Responsible, reliable, with a high level of precision and attention to detail in work.
- Structured and goal-oriented approach, along with effective communication skills (intercultural communication competency).
Information about our client:
My client is a successful family-owned company.
The company distributes preparations in more than 30 countries and has its main export markets in Western and Eastern Europe as well as in the Middle East.
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
I look forward to your application!