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 lookingfor a:
Manager Labelling and Regulatory Submissions
Your Job
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
Manages creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical, safety department)
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
Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level
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
Your Profile
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 professional experience in regulatory affairs with a profound track record in labeling activities for innovator drugs on a global level
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
We offer
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 receiveyour application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don't hesitate to contact us.
Agencies only by prior agreement for the specific job opportunity.
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