(Senior) Regulatory Affairs Manager (m/f/x) | Frankfurt | Pharma
In this role, you will be playing a key role in marketing authorizations and life-cycle management of medicinal products in the area of foundational products, taking into account the regulatory and legal requirements in the markets. You will be assigning, coordinating, and monitoring the processing of change control applications with the help of external CROs.
What will your tasks as "(Senior) Regulatory Affairs Manager" be?
- Coordination and preparation of marketing authorization dossiers, in particular Module 1, for national marketing authorization applications worldwide in close cooperation with internal specialist departments and external partners.
- Strategic planning, efficient implementation of marketing authorization procedures and ensuring their compliance with internal and external requirements
- Implementation and continuous follow-up of the required life-cycle management activities
- Coordinating, managing, and monitoring the regulatory implementation of change control procedures as well as implementing the resulting regulatory changes
- Preparation, updating and implementation of country-specific product information texts
- Takeover of outsourcing projects incl. control and follow-up of outsourced activities
- Preparation of and participation in scientific consultations with regulatory authorities worldwide as well as support during inspections
- Participation in the evaluation of dossiers within the scope of due diligence activities
Your requirements as "(Senior) Regulatory Affairs Manager"?
- Degree in natural sciences, preferably pharmacy, chemistry, or biology
- 3-5+ years of professional experience in a hands-on regulatory affairs role
- Very good knowledge of marketing authorization of medicinal products
- Comprehensive knowledge of regulatory guidelines and formal requirements of LCM activities, knowledge of combination products or medical devices is a plus
- Very good knowledge of English, German or another foreign language would be a plus
- An analytical and structured way of working with a strong attention to detail and strong organizational skills plus the ability to work in a team
- Experience in the area of project management and working with/managing CROs
Information about our client :
Our client is a leading pharmaceuticals & medical devices companies in Europe. The company is more than 100 years old and it's more than 3000 employees are operating in 50+ countries. The diverse specialties of the company include medical aesthetics and neurotoxin therapy. The company is also active in research, development, and distribution of further innovative products (innovative health, wellness and beauty).
I look forward to your application!