Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistAs our Senior Regulatory Affairs Specialist, you will be responsible for obtaining and maintaining parallel trading licenses and preparing packaging materials according to SOPs, WIs, and applicable guidelines. Your work will ensure regulatory compliance, smooth production processes, and timely market access. You will handle dossiers, artwork, and documentation, while also staying up to date with regulatory requirements in your assigned end market.In this role, you will:· Prepare and submit dossiers to acquire and maintain parallel trading licenses.· Create and maintain packaging materials, artwork files, mock-ups, and item lists.· Proofread packaging components, application files, and item lists to ensure accuracy.· Manage and archive regulatory documentation, including packaging materials and authority-approved files.· You will also communicate directly with health authorities and external printing houses, monitor regulatory updates, and implement changes as required. Beyond your daily responsibilities, you will contribute to continuous improvement projects, training, and updates of working instructions and guidelines. Ad-hoc assignments from your manager may also be part of your role.About you:We are looking for a detail-oriented and proactive professional who thrives in a structured, regulated environment and enjoys collaborating with multiple stakeholders.You bring:· A Master’s or Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or an equivalent field.· Minimum 2 years of experience in the pharmaceutical industry.· Professional proficiency in English (B2 level or higher).Experience in at least one of the following areas:· QA or RA within pharma.· Interaction with regulatory authorities.· Handling medicine forms and packaging materials in repackaging processes.· Experience with repackaging processes and machinery.· Proficiency in Adobe InDesign, Illustrator, Photoshop; knowledge of EULER (braille) and text comparison software.· Fluent in English (written and verbal) and good knowledge of local language (written and verbal)· Residence in the country where the role is based and a valid work permit.Skills and competencies that will make you succeed You have strong knowledge of regulatory dossiers and parallel distribution procedures and a solid understanding of packaging material design, proofreading, and archiving. You communicate effectively with authorities and external partners, and your work is characterised by accuracy and attention to detail in regulatory submissions. You are able to perform under strict guidelines and deadlines, while also maintaining a continuous improvement mindset, always seeking opportunities to optimise processes and systems.