Regulatory Affairs Manager Labeling + Submissions

We are growing, grow with us!
Cencora 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:

Regulatory Affairs Manager Labeling + 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
• 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 
• Revision of approval documents including tracking of updates and respective handling of 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
• Professional interaction with clients and Health Authorities
• Coordination of project teams with internal / external staff and Regulatory Partners on a world-wide 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 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.