Regulatory Affairs Manager - Labelling (m/w/d) | Bayern | Pharma
Are you looking for a dynamic company with daily new challenges and opportunities?
What will your tasks as Regulatory Affairs Manager - Labelling be?
- Coordination and timely response to notices of defects
- Creation (e-CTD) and submission of electronic marketing authorisation packages for drugs to the BfArM
- Cooperation with the Launch Management, Portfolio Management, Quality Assurance and Pharmacovigilance departments
- Finalisation of German technical information and package insert on the basis of English EU procedure texts (MRP/DCP)
- Timely coordination of artwork for packaging materials and patient and professional information
- Degree in science (e.g. pharmacy, biology, food chemistry or similar).
- Experience with BfArM Submission Operations (e-CTD, CESP; new submissions,
- authorisation masks, variations, notifications of changes)
- Knowledge in the maintenance of XEVMPD (EMA regulatory database).
Essential knowledge & skills:
- Excellent written and communication skills in English and German
- Independent, precise, well-structured and fast way of working
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I look forward to your application!