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:
Senior Manager Regulatory Affairs Labeling (f/m/d)
- Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles
- Manage creation and maintenance of CCDS/CCSI/RSI, as applicable, in collaboration with relevant departments/expert functions responsible for CCDS section content
- Ensures communication to internal / external stakeholders regarding new and updated CCDSs
- Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee, Global labelling boards) as necessary
- Ensuring that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standards
- Planning and expediting the approval projects using the internally available or client-based software tools including databases and document management systems
- Providing regulatory expertise to regulatory programs and projects as well as to clients
- General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
- Presenting seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiences
- Creation, revision, editing and maintenance of regulatory documentation
- Professional interaction with clients and Health Authorities
- Coordination of project teams with internal / external staff and Regulatory Alliance Partners on a world-wide level
- Participation in strategic regulatory issues incl. definition of suitable methods of resolution
- Technical support to business development with particular focus on Labeling activities and adjacent areas on EU level and preferably also on global level
- You speak fluent business English or English is your mother tongue, preferably you also have skills in another EU language
- 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 at least 5 -7 years of professional experience in regulatory affairs with a profound track record in labeling activities
- You bring experience in handling of marketing authorizations and their lifecycle management
- You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region
- You have an affinity for databases, labeling software tools 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.