We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity.
PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.
The success of our company grows with the excellent expertise and the high motivation of our employees.
If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.
To strengthen our successful team, we are looking for a:
Manager Regulatory Submissions
- 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 a 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 reduced number of hours
- 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.