Regulatory Affairs Specialist, Scotland.
A member of the Regulatory Affairs, Clinical & Compliance Team based in the UK.
The Regulatory Specialist is responsible for preparing accurate, clear and concise regulatory documents; and for providing knowledgeable input to interdisciplinary project teams and management. You assess current/emerging regulations, guidance documents and corporate/industry standards for impact on the business area. You collaborate effectively with partners across project teams, their party vendors and/or development partners to ensure effective project communication and coordination for submission assignments and special projects.
The Regulatory Affairs Specialist is responsible for managing site-specific regulatory compliance activities in line with corporate and divisional objectives.
- Collaborate with multi-disciplinary teams, prepare eCTD DMFs and annual reports, regulatory support files, EDQM Certificates of Suitability, and other product submissions or regulatory documents as required
- Develop and maintain regulatory affairs internal policies and procedures, and provide internal trainings when required.
- Provide regulatory support to internal customers with respect to legislative requirements for the market place, mainly EMEA.
- Work closely with various site teams to review new and existing regulations, guidance documents and standards, and prepare comments based on impact to site, product and business.
- Compile, review and maintain In Vitro Diagnostic product submissions, Technical Files, and labelling for completeness and quality for such products.
- Support and participate in site-wide projects and global new product development projects requiring regulatory input and representation to ensure compliance with internal product commercialization process (PCP) and global regulations.
- Review and approve product labelling/marketing materials for compliance with applicable regulations and standards.
- Support site teams in post-market surveillance and vigilance activities.
- Support and participate, where required, in regulatory/quality audits, customer audits and technical meetings when applicable.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales