- Apie įmonę
SENIOR REGULATORY AFFAIRS SPECIALIST
BalticCRO is an outsourcing and consultancy services provider for the pharmaceutical industry. We are operationally focused on providing clinical research, pharmacovigilance, regulatory affairs, product reimbursement and market access support services. Currently we are looking for an experienced professional to join our team in a Senior Regulatory Affairs Specialist role.
- Manage and facilitate all product registration and licence maintenance related activities;
- Manage regulatory activities for a portfolio of Pharmaceuticals, Medical Devices, Cosmetics, Nutriceuticals;
- Compile, coordinate and monitor applications for registration, renewals, variations in accordance to the national and EU legislation, customer requirements and applicable procedures;
- Interact with regulatory authorities, respond to questions and handle applications/requests;
- Review and approve promotional materials;
- Review and approve product labelling and artworks;
- Translate/update the specific product dossier documents, i.e. Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), labelling etc. into Lithuanian or English language;
- Cooperate and supervise internal and external resources on assigned projects and assure that all standards of work, timelines and budgets are met;
- Maintain a portfolio of products, which are subject to monitoring/renewal of the validity of the license by identifying strategies for the reduction of unforeseen risks;
- Perform regulatory intelligence, and identify potential legislative changes that could affect the assigned portfolio.
Experience, required skills and competencies
- Education in Science/Health discipline;
- Experience in pharmaceutical Regulatory Affairs in an international environment;
- Excellent knowledge of English;
- Decision making skills;
- Careful planning to achieve accurate and timely results.
- Interesting, dynamic and diverse work in a young and growing company;
- Broad opportunities for self-expression and professional growth;
- Contributing to challenging tasks and achieving ambitious targets;
- Office in the old town of Kaunas, with flexible working hours and partial home-office possibility;
- Friendly team, coffee and snacks, team buildings.
Please send your CV and cover letter by August 15th to career@balticCRO.com