QA: Regulatory Compliance Specialist
Location: Ringaskiddy, hybrid
Term: 18 months
Salary: €24/hr +
Here at Hays, we are looking for a Regulatory Compliance Specialist to join our pharmaceutical client in Cork.
Our client is a world leader in the Life Science industry, engaging in exciting work and research every day.
The Regulatory Compliance Specialist is responsible for supporting tasks and projects related to management of Regulatory Compliance and new product submissions.
These activities include QA/Compliance support for worldwide submissions of new drug applications and post approval changes, change control support, manufacturing support and manufacturing license maintenance.
Will join a team of 3-4 QA Specialists working primarily on reg compliance activities.
Team supports the registration and approval process for new products being submitted to the various health authorities.
The team supports GMP re-certifications for the site for markets such as Taiwan, Japan, China, etc. The team support onsite, remote, and paper based regulatory audits.
- Point of Contact to request, source and provide relevant regulatory documentation to support miscellaneous regulatory requests such as paper-based inspections (e.g. Taiwan, Japan etc).
- In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses.
- Notarisation and legalisation management.
- In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests.
- Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the company sections are accurate and consistent across all products.
- Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows.
- In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required.
- Familiarisation with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared.
- Regulatory support for routine manufacturing / Quality operations.
- Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc
Education and Skills:
- QA experience in pharma industry
- BSc/ BA in related field
- Regulatory Systems
- Manufacturing Licence experience
- eCTD viewer
Key Competencies Required:
- Collaboration and teamwork
- Problem solving and attention to detail
- Customer focused
- Clear communication skills
- Adaptable and flexible
If you are interested in the opportunity reach out today!