Manager Labelling and Regulatory Submissions Lisboa

Manager Labelling and Regulatory Submissions
Lisboa
Lisboa, Lisboa, Portugal

Social network you want to login/join with:

Manager Labelling and Regulatory Submissions, Lisbon

Client: Pharma
Lex

Location: Lisbon, Portugal

Job Category: Other

EU work permit required: Yes

Job Reference: 727bd63e5520

Job Views: 23

Posted: 23. 01. 2025

Expiry Date: 09. 03. 2025

Job Description:

Your Job

• Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (Sm
  PC, PIL, Labelling) in EU and also for
  - 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
  - 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 Pharma
  Lex 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 Pharma
  Lex 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
  - 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.