Regulatory Affairs Specialist

SGS

  • Cork
  • Contract
  • Full-time
  • 17 days ago
Company DescriptionSGS 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 99,500 employees, we operate a network of more than 2,500 offices and laboratories around the world. We deliver global service with local expertise, to market leading clients across 10 different industries worldwide.Our client services include providing SGS Regulatory Affairs and technical support staff on-site to fulfill staffing requirements (Scientific In-sourcing), all under the supervision and guidance of ISL technical and operational teams. Like all SGS personnel, they are committed to upholding stringent technical and GMP standards, ensuring the safety of medications for the multitude of patients relying on the products we test.Due to growth, we have an exciting opportunity for an experienced Regulatory Affairs Specialist to join our growing Scientific In-sourcing team.Job DescriptionWhat 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 MA's 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.
Qualifications
  • Level 7 or Bachelors is required.
  • 2 + Years experience in a similar role.
  • Preferably working knowledge of 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.
Additional InformationWe offer you:An opportunity to develop and international career in a friendly, supportive, approachable working environment with a down-to-earth culture. Continuous learning with the chance to expand and enrich your career with our dedicated training team to support your career development opportunities across SGS.
  • An attractive compensation and benefits package including
  • Bonus
  • Healthcare
  • Pension
  • Enhanced annual leave
To apply please submit your CV.We are an equal opportunity employer and value diversity at our company.

SGS