AdresseRegulatory Affairs Manager (m/f/d)
Aufgaben
- Assessing Regulatory strategies
- Providing Regulatory input into portfolio discussion and pipeline discussion
- Filing and follow up of applications for MAs, variations, PSURs and other regulatory actions, ensuring timelines are kept
- Artwork and copy approval from Regulatory perspective including recommendation for further improvement
- Active participation in life cycle management considering regulatory and business needs while paying attention to cost aspects
- Independently managing assigned projects
- Ensuring smooth business processes by preventing disruptions due to regulatory aspects
- Supporting the development of Regulatory claims
- Supporting brand development from Regulatory Affairs perspective
- Managing requests of authorities
- Taking ownership of assigned projects
- represent Regulatory function as leading and knowledgeable partner in business development
- Enhancing Regulatory knowledge within the team by providing learnings from own projects which are applicable to other brands
- Conducting tasks as a business partner and owner of the product from regulatory perspective
- Experience in Drug Reg Affairs
- Degree in natural sciences, Pharmacy or Medicine
- Experience in all types of application for Marketing Authorisations
- Experienced with Licence Maintenance & Life Cycle Management
- Very good communication skills (in order to transfer regulatory knowledge to non-regulatory audience)
- Fluency in English and German
- Extensive training and a very friendly team
- Above average salary and benefits package
- Opportunities for personal and professional growth
- Great flexibility incl. 40% homeoffice
- Excellent working conditions
Silvio Di Meglio
Tel.: 0049-(0)89-80913072-1
