We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Manager Regulatory Affairs EU and International (f/m/d)
Locations: Germany, Bulgaria, Spain, United Kingdom, and Italy
- Preparation of regulatory processes to gain and maintain European and non-European marketing authorizations for human and veterinary medicinal products (new marketing authorization application, renewal, variations, MAH transfer), preferably including experience in cosmetics, food supplements and/or herbal products
- Communication and interaction within the project team, with customers, local partners and health authorities in a regional and/or an international context
- Coordination and management of project teams with internal and external staff and global partners incl. reporting and oversight activities and responsibilities
- Responsible for the planning, filing and prosecution of Regulatory Affairs projects
- Preparation and revision and compilation of the informative texts for healthcare professionals and patients (CCDS, SmPC, PIL, Labeling)
- Revision of approval documents including tracking of updates and respective handling of databases and document management systems
- You speak fluent business English, a second language is preferred
- You have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor’s degree in science, engineering or mathematical domain
- You have respective professional experience in regulatory affairs in the EU and preferably also in international markets (e.g. LATAM, MENA, APAC region)
- You bring experience in handling of marketing authorizations and their lifecyle management with a focus on the EU. Experience in regulatory applications and handling of non-EU marketing authorization procedures is appreciated
- You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region
- You bring experience in managing and coordinating project teams, preferably including experience in project, team and budget oversight and management
- You have an affinity for databases and project management software and are used to closely monitor and adhere to timelines
- You are a team player, communicative, conscientious, accurate and responsible
- Confident with MS Excel and MS Word as well as databases and document management systems
- Diverse and challenging job
- Open and appreciative corporate culture
- Flexible working hours based on trust
- Possibility to work from home
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.