Head of Regulatory Affairs Manager (m/f/x) | Rhein-Main Area | Pharma
Every day we take on the challenge of making a positive contribution. As Head of Regulatory Affairs Germany, you will be responsible for securing a strong commitment to compliance with the German Medicines Act to maintain national marketing authorisations, support the continuous supply of marketed products and the launch of the product portfolio of in a targeted and timely manner.
What will your tasks as Head of Regulatory Affairs Manager be?
- Lead the regulatory team to ensure agreed objectives are achieved and responsibilities are delivered; develop talent and promote a culture of learning and collaboration
- Manage projects related to regulatory affairs in collaboration with regional regulatory functions or country-specific commercial functions in a timely and cost-effective manner
- Perform regulatory launch management with a focus on generic molecules in close collaboration with Supply, Quality, Marketing and Medical to ensure timely and successful commercialisation of the product
- Oversee and enforce print submission approval as an information officer (74a AMG) for products marketed by all German companies
- Drive the Regulatory team to meet global and regional standards and agreed deadlines (e.g. timely submission of safety data, high quality translations, RTF submissions, pharmaceutical documentation compliance)
- Doctor or master's degree in Natural science or pharmaceutical
- At least 10 years of experience in Leadership of larges team in an international pharmaceutical Company
- Proven experience in regulatory affairs management in the pharmaceutical industry of German Pharmaceutical law
- depth experience of launch of generics, name changes, re branding or similar as a Project Management
Essential knowledge & skills:
- Excellent written and communication skills in English and German
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!