SGS is the world's leading Inspection, Verification, Testing and Certification company. We are recognised as the global benchmark for quality and integrity. With more than 93,000 employees, we operate a network of more than 2,600 offices and laboratories around the world. We deliver global service with local expertise, to market leading clients across 10 different industries worldwide. At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership. Job Description We have an exciting opportunity for a driven and knowledgeable Regulatory Affairs Specialist to join our team in Cork. What You'll do Preparation and submission of new Marketing Authorisation applications Maintenance of approved marketing authorisation dossiers including submission of variations, renewals and follow-up measures. Preparation of the above submissions in collaboration with other departments and partner companies. Preparation of responses to queries from regulatory authorities and partner companies. Publishing of regulatory submissions using relevant Manager Software. Review and approval of product artworks to ensure compliance with the relevant MA. Interactions with management and partner companies and provision of documentation required to support the MAs they have responsibility for. Regulatory compliance activities and GMP documentation (specifications, batch records etc.). Maintenance of Wholesale Distribution Authorisation. Maintenance of Regulatory forms, logs and databases with up-to-date regulatory information. GMP Cognisance and compliance with all the necessary elements of process paperwork including Standard Operating Procedures, system logs, stock control systems, machine logs, process documentation and specifications. Responsible at all times for plant and process hygiene within the area of operation. Vigilance for product or process defects and the reporting of same. Additional Information Level 7 or Bachelors is required. Past experience within a similar capacity role is desirable. Working knowledge eCTD manager software. To be vigilant when operating machinery and comply with all safety mechanisms. Faulty or unsafe equipment is efficiently reported and rectified. Wearing correct gear and equipment necessary for operation at all times. Co operate with training and screening by the company representing SGS in a professional light. Excellent communication and organisation skills due to the high volumes of documentation. What We Offer Excellent remuneration and benefits package. Career development opportunities within a global organisation. Collaborative and supportive work environment. Training and development opportunities. Candidates must be immediately eligible to work in Ireland. We are an equal opportunity employer and value diversity at our company. Skills: Regulatory Affairs