Regulatory Affairs Manager

TFS is now looking for a well-experienced Regulatory Affairs Manager who appreciates a flexible working environment filled with interesting and stimulating assignments.TFS is working with both international and national projects within many therapeutic fields.The Regulatory Affairs department is involved in plenty of exciting projects in various phases, such as registration, strategy planning in early development phase, clinical trial application and marketing approval as well as maintenance after approval. The main responsibilities of the Regulatory Affairs Manager will include: - Preparation, review and compilation of regulatory submissions - Liaison with authorities - Advice/answers to regulatory issues/questions - Preparation of prescribing documents (SPCs, Package insert labels) - Maintain a high level of competence regarding international regulatory requirements and regulatory procedures Requirements/qualifications: - Suitable academic education in life science such as pharmaceutical science, medicine, biomedicine, biology or similar - At least 3 years experience from working with regulatory affairs within the pharmaceutical industry or regulatory authorities - Good communication skills in spoken and written Swedish and English - Knowledge of Medical Device is an advantage TFS Trial Form Support will offer: A dynamic and growth-oriented organization with a work environment distinguished by professionalism, integrity and responsibility.Welcome to join us and to contribute in placing TFS Trial Form Support among the top 10 worldwide CROs. Your job will make a difference! We are looking forward to receiving your application with included CV and a personal letter.