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Regulatory Affairs and Labelling Manager
hace 3 meses
Your Role
Engage in the formulation, revision, and assembly of informative materials intended for healthcare professionals and patients (SmPC, PIL, Labelling) within the EU and for international markets, ideally involving the development of target product/labelling profiles. Oversee the creation and upkeep of CCDS/CCSI/RSI, collaborating directly with pertinent departments and expert functions responsible for the content of CCDS sections (e.g., from medical and safety departments). Facilitate communication with internal and external stakeholders regarding new and updated CCDSs. Address deviations and compliance concerns to the labelling governance bodies (e.g., Safety Monitoring Committee, Global Labelling Boards) as required. Possess experience in labelling documentation and informative texts for innovator pharmaceuticals at a global (headquarter) level. Ensure that regulatory affairs, development consulting, and scientific affairs programs and projects are executed to the highest standards. Strategically plan and accelerate approval projects utilizing available internal or client-based software tools, including databases and document management systems. Provide regulatory expertise to various regulatory programs and projects, as well as to clients. Offer general guidance (consultancy) to PharmaLex staff and clients concerning Regulatory Submissions & Labelling activities, including updates on emerging trends and legislative changes. Deliver seminars and presentations on behalf of PharmaLex internally, for clients, and for professional audiences. Create, revise, edit, and maintain regulatory documentation. Engage in professional interactions with clients and Health Authorities. Coordinate project teams with internal and external personnel and Regulatory Alliance Partners on a global scale. Participate in strategic regulatory discussions, including the identification of appropriate resolution methods. Provide technical support to business development, particularly focusing on Labelling activities and related areas at the EU level and preferably on a global scale.Your Qualifications
Proficient in business English or a native English speaker, with additional skills in another EU language preferred. Hold a degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in a scientific, engineering, or mathematical field. Have professional experience in regulatory affairs with a strong background in labelling activities for innovator pharmaceuticals on a global scale. Experience in managing marketing authorizations and their lifecycle is essential. Possess a solid understanding of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region. Demonstrate an affinity for databases, labelling software tools, and project management software, with a commitment to monitoring and adhering to timelines. Be a collaborative team player, with strong communication skills, conscientiousness, accuracy, and responsibility. Competent in MS Excel and MS Word, as well as databases and document management systems.What We Provide
A diverse and rewarding position. An open and respectful corporate culture. Flexible working hours based on trust. Opportunities for reduced working hours. Options to work remotely. Continuous development opportunities through knowledge, experience, and training.